Paclitaxel Coated Balloon for Esophageal Strictures

(PATENT-E Trial)

Recruiting at 35 trial locations

Overseen By Erika Wang

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: GIE Medical

Must not be taking: Anticoagulants, Antiplatelets, Steroids, others

Disqualifiers: Pregnancy, Eosinophilic esophagitis, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

198 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for benign esophageal strictures, which are non-cancerous narrowings in the esophagus that can make swallowing difficult. The study aims to determine if a drug-coated balloon, the ProTractX3™ (also known as the Paclitaxel Coated Balloon), is safe and effective compared to the standard treatment of endoscopic dilation. Participants should have a benign esophageal stricture treated with dilation at least twice and experience difficulty swallowing. Eligible participants could help researchers find better ways to manage this condition. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial requires participants to stop using chronic systemic steroids for at least 4 weeks before starting the trial. If you are on anticoagulant or antiplatelet medications, they must be managed safely according to guidelines before the procedure. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the ProTractX3™ drug-coated balloon (DCB) is being tested for treating non-cancerous narrowing of the esophagus. This treatment uses a balloon coated with paclitaxel, a drug that helps prevent esophageal narrowing. Previous studies have found that drug-coated balloons are generally well-tolerated in other conditions, such as blocked blood vessels.

Specific information about the safety of the ProTractX3 DCB for use in the esophagus is still being gathered. The trial's advanced stage suggests some evidence of safety from earlier research. Serious safety issues with the ProTractX3 DCB would likely have prevented it from reaching this stage.

Detailed information about side effects or negative reactions in humans is not yet available. Participants in the trial will help researchers collect more comprehensive safety data. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

The GIE Medical ProTractX3 TTS DCB is unique because it uses a drug-coated balloon technology to treat esophageal strictures, a departure from the traditional method of endoscopic dilation. This treatment stands out due to its use of paclitaxel, a medication that helps prevent the re-narrowing of the esophagus by inhibiting cell proliferation. Researchers are excited about this approach because it could offer longer-lasting relief compared to standard dilation, potentially reducing the need for repeated procedures.

What evidence suggests that the ProTractX3™ DCB is effective for esophageal strictures?

Research has shown that paclitaxel-coated balloons, such as the ProTractX3™, may help treat non-cancerous narrowing of the esophagus. In this trial, participants may receive the ProTractX3™ balloon, which releases paclitaxel, a drug that slows tissue growth and helps keep the esophagus open longer after widening. Early results suggest these drug-coated balloons might outperform standard treatments, used in the control arm, in maintaining esophageal openness. While more data is gathered, the mechanism of these balloons supports their potential effectiveness. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

Adults over 22 with benign esophageal strictures, who've had at least two previous dilations in the last year. They must have a stricture less than 5cm long and be able to follow up. Pregnant women, those with certain medical conditions or allergies to paclitaxel, and patients on chronic steroids (unless they stop) can't join.

Inclusion Criteria

Minimum esophageal lumen diameter <13 mm

Strictures ≤5cm in total length

Ogilvie Dysphagia Score of ≥2

Exclusion Criteria

Current participation in another pre-market drug or medical device clinical study that has not reached it's primary endpoint

I have been diagnosed with eosinophilic esophagitis.

Life expectancy of less than 24 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with the ProTractX3™ DCB or standard endoscopic dilation

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Long-term Follow-up

Annual assessment of reintervention rates

Annually

What Are the Treatments Tested in This Trial?

Interventions

• Control
• GIE Medical ProTractX3 TTS DCB

Trial Overview The trial is testing the ProTractX3™ Drug-Coated Balloon (DCB) against a control treatment for safety and effectiveness in treating non-cancerous narrowings of the esophagus that make swallowing difficult.

How Is the Trial Designed?

Group I: GIE Medical ProTractX3 TTS DCB Experimental Treatment 1 Intervention

The ProTractX3 Drug-coated balloon is a 0.035" guidewire compatible over-the-wire catheter.

Group II: Control Active Control 1 Intervention

Standard of Care Endoscopic Dilation

Who Is Running the Clinical Trial?

GIE Medical

Lead Sponsor

Trials

5

Recruited

400+

Published Research Related to This Trial

In a study of 124 patients with advanced or recurrent esophageal cancer who had previously received platinum-based chemotherapy, paclitaxel (PTX) showed higher objective response rates (25.7% vs. 10.3%) and disease control rates (60.0% vs. 34.6%) compared to docetaxel (DTX).

While both treatments had similar overall survival rates (6.1 months for DTX vs. 7.2 months for PTX), PTX was associated with fewer severe side effects, such as grade 3-4 neutropenia (21.1% for PTX vs. 48.8% for DTX) and febrile neutropenia (5.3% for PTX vs. 20.9% for DTX), making it a more feasible option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A retrospective comparison of docetaxel and paclitaxel for patients with advanced or recurrent esophageal cancer who previously received platinum-based chemotherapy. Mizota, A., Shitara, K., Kondo, C., et al.[2018]

The DCF regimen (docetaxel, cisplatin, and 5-FU) combined with prophylactic pegfilgrastim showed promising histopathological response rates in patients with esophageal cancer, indicating its effectiveness as preoperative chemotherapy.

Despite achieving the desired histopathological responses, the use of pegfilgrastim did not sufficiently prevent febrile neutropenia, with 29.7% of patients experiencing this adverse effect during the first treatment cycle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative docetaxel, cisplatin, and fluorouracil treatment with pegfilgrastim on day 7 for patients with esophageal cancer: A phase II study. Maeda, O., Fukaya, M., Koike, M., et al.[2022]

Drug-coated balloon (DCB) percutaneous transluminal angioplasty (PTA) shows promise as a safe and feasible treatment for patients with symptomatic high-grade intracranial atherosclerotic disease (ICAD), potentially offering advantages over best medical treatment alone.

Current clinical studies suggest that DCB-PTA could be a viable alternative to traditional therapies for ICAD, especially given the high rates of recurrent stroke in patients with severe stenosis, although more data is needed to fully establish its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Device profile of different paclitaxel-coated balloons: Neuro Elutax SV, Elutax '3' Neuro and SeQuent Please NEO for the treatment of symptomatic intracranial high-grade stenosis: overview of their feasibility and safety. Gruber, P., Remonda, L.[2020]

This case report is the first to show that nab-paclitaxel can successfully treat patients who have severe hypersensitivity reactions to paclitaxel and docetaxel.

Nab-paclitaxel is demonstrated to be a safe alternative chemotherapy option for patients who cannot tolerate traditional taxane treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful treatment with nab-paclitaxel after hypersensitivity reaction to paclitaxel and docetaxel. de Leon, MC., Bolla, S., Greene, B., et al.[2021]

In a study of 66 patients with locally advanced inoperable esophageal cancer, the combination of definitive chemoradiation (dCRT) with paclitaxel and carboplatin (TC) showed similar overall survival rates compared to cisplatin (CDDP) after 3 years, with median survival durations of 18 months for TC and 13 months for CDDP.

The TC regimen had a significantly better toxicity profile, with lower rates of side effects such as emesis (25% for TC vs. 93% for CDDP) and neutropenia (13% for TC vs. 79% for CDDP), making it a safer alternative for patients undergoing treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Definitive chemoradiation in locally advanced inoperable esophageal cancer patients - Retrospective analysis of different chemotherapy regimens in a tertiary cancer centre. Nagarajan, A., Nureja, BY., Ravichandar, R., et al.[2022]

A novel drug-coated balloon (DCB) with 6 μg of paclitaxel (Ptx) per mm² was shown to significantly increase drug concentration in the vessel wall compared to a standard DCB with 3 μg/mm², potentially enhancing its effectiveness in preventing restenosis.

Using a single balloon with 6 μg Ptx/mm² not only doubles the drug delivery compared to the 3 μg/mm² balloons but also simplifies the procedure and may lower healthcare costs by reducing the need for multiple balloons.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel paclitaxel coated balloon with increased drug transfer for treatment of complex vascular lesions. Gemeinhardt, O., Schnorr, B., Speck, U., et al.[2021]

Ongoing Phase III trials are exploring the effectiveness of paclitaxel in treating various cancers, including ovarian, breast, lung, and head and neck cancers, indicating its potential as a front-line and adjuvant therapy.

Recent studies have also identified paclitaxel's activity in additional cancer types such as esophageal, bladder, and endometrial cancers, suggesting its broad applicability and encouraging further research into its therapeutic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paclitaxel: current developmental approaches of the National Cancer Institute. Arbuck, SG.[2015]

In a study involving 142 patients across three trials, there was no significant difference in overall mortality between those treated with paclitaxel-eluting devices and those who were not, suggesting that paclitaxel may not increase mortality risk in these populations.

While a statistically nonsignificant trend towards higher late mortality was observed in the FINNPTX trial for the paclitaxel group, the small sample sizes in individual trials warrant caution and further investigation through larger meta-analyses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

No Difference in Mid-term and Long-Term Mortality After Vascular Paclitaxel Exposure. Björkman, P., Weselius, EM., Venermo, M.[2021]

In a phase II trial involving 30 patients with advanced esophageal cancer, the combination of paclitaxel and cisplatin resulted in a significant anti-tumor response, with 59.3% of patients showing major objective responses, including 5 complete responses.

The treatment was associated with manageable toxicity, primarily alopecia and grade 3 to 4 neutropenia in 17.9% of patients, suggesting that this regimen can be a viable option for patients with advanced esophageal cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Phase II study of paclitaxel and cisplatin for advanced squamous-cell carcinoma of esophagus]. Huang, J., Cai, RG., Meng, PJ., et al.[2015]

In a study of 135 patients treated with paclitaxel drug-coated balloons (DCB) for in-stent restenosis (ISR), DCB was found to be significantly less effective for drug-eluting stent (DES) ISR compared to bare metal stent (BMS) ISR, with higher rates of binary restenosis (57% vs. 29%) and target lesion revascularization (TLR) (46% vs. 18%).

The reduced efficacy of DCB treatment was particularly notable in DES-ISR located in degenerated saphenous vein grafts (SVGs), where TLR was required in 72% of cases, compared to only 14% for BMS-ISR, highlighting the challenges of treating DES-ISR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug Coated Balloon Is Less Effective for Treatment of DES In-Stent Restenosis Both in Native Coronary Arteries and Saphenous Vein Grafts: Results From a Bicenter Registry. Resch, M., Ostheim, P., Endemann, DH., et al.[2019]

In a multicenter trial involving 171 patients, the novel paclitaxel-coated drug-coated balloon (DCB) significantly reduced late lumen loss by 0.92 mm compared to uncoated balloon angioplasty (POBA) at six months, indicating better efficacy in preventing restenosis.

Patients treated with the DCB showed improved walking ability and a much lower rate of target lesion revascularization (1.3% in the DCB group vs. 18.7% in the POBA group) after 12 months, demonstrating both safety and effectiveness of the DCB in treating peripheral artery disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of a novel paclitaxel-nano-coated balloon for femoropopliteal angioplasty: one-year results of the EffPac trial. Teichgräber, U., Lehmann, T., Aschenbach, R., et al.[2020]

In a study of 127 patients with locally advanced esophageal squamous cell carcinoma, those treated with paclitaxel and cisplatin (TP) showed significantly better local progression-free survival (LPFS) compared to those treated with 5-fluorouracil and cisplatin (PF), with rates of 74% versus 48%.

Surgery combined with neoadjuvant chemoradiation (NeoCRT + S) resulted in a significantly higher LPFS of 71% compared to 39% for definitive chemoradiation (DefCRT), suggesting that both surgical intervention and the use of paclitaxel can enhance local disease control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved local control by surgery and paclitaxel-based chemoradiation for esophageal squamous cell carcinoma: results of a retrospective non-randomized study. Hsu, FM., Lin, CC., Lee, JM., et al.[2022]

The Stellarex® drug-coated balloon (DCB) effectively delivers a low dose of paclitaxel to treat vascular lesions, utilizing a unique hybrid formulation that ensures drug integrity and release during use.

Clinical data indicate that Stellarex maintains long-term effectiveness in treating patients without any significant safety concerns, suggesting it is a reliable option for vascular interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stellarex drug-coated balloon: a technology evaluation. Nerla, R., Castriota, F., Cremonesi, A., et al.[2021]

Citations

1. med.unc.edu med.unc.edu/medicine/news/gie-medical-announces-first-patient-enrolled-in-patent-e-benign-esophageal-stricture-treatment-study/

GIE Medical Announces First Patient Enrolled in PATENT- ... The study is evaluating the safety and efficacy of the first of its kind ProTractX3™ TTS drug coated balloon (DCB) and the first patient was ...

2. giemedical.com giemedical.com/currentnews

gie medical news The study is evaluating the safety and efficacy of the first of its kind ProTractX3™ TTS drug coated balloon (DCB), and the first patient was enrolled at ...

3. clinicaltrials.cedars-sinai.edu clinicaltrials.cedars-sinai.edu/view/PR2052

Paclitaxel Coated Balloon for the Treatment of Chronic Benign ... The purpose of this study is to assess the safety and effectiveness of an experimental device called the ProTractX3 TTS drug-coated balloon (DCB)

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05561114

Study Details | NCT05561114 | Paclitaxel Coated Balloon ... Study Overview. Brief Summary. To evaluate the safety and efficacy of the ProTractX3™ DCB for the treatment of benign esophageal strictures.

5. withpower.com withpower.com/trial/phase-3-constriction-pathologic-9-2022-cfd64

Paclitaxel Coated Balloon for Esophageal Strictures Trial Overview The trial is testing the ProTractX3™ Drug-Coated Balloon (DCB) against a control treatment for safety and effectiveness in treating non-cancerous ...

6. clinicaltrial.be clinicaltrial.be/en/details/22689?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Paclitaxel Coated Balloon for the Treatment of Chronic bE... To evaluate the safety and efficacy of the ProTractX3™ DCB for the treatment of benign esophageal strictures. Trial design. Interventions. 1.

7. giemedical.com giemedical.com/news/gie-medical-announces-first-patient-enrolled-in-patent-b-benign-bowel-stricture-treatment-study

GIE Medical Announces First Patient Enrolled in PATENT ... The large, multicenter randomized controlled clinical trial is evaluating the safety and efficacy of the ProTractX3™ TTS drug coated balloon ...