Novel Rigidizing Overtube for Gastrointestinal Cancer

Recruiting at 1 trial location

Overseen By Michael Mercado, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Disqualifiers: Pregnancy, Nursing, Sigmoid lesions, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

66 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool, the Pathfinder Endoscope Overtube, to determine if it makes endoscopic submucosal dissection—a specific type of cancer surgery—quicker and safer. Researchers aim to find out if this tool enhances doctors' stability and control during operations, potentially reducing complications. Participants suitable for this trial have been referred for surgery to remove certain challenging growths in the colon, such as those with scars or specific tumor types.

As an unphased trial, it allows patients to contribute to innovative surgical advancements that could enhance future procedures.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Pathfinder Endoscope Overtube is safe for gastrointestinal procedures?

Research has shown that the new rigidizing overtube, such as the Pathfinder Endoscope Overtube, is generally easy for patients to handle. In one study with 66 patients, the overtube helped keep the scope steady, allowing doctors to perform procedures more smoothly. This finding suggests that the overtube could make the procedure safer and more effective.

Earlier findings also indicate that for hard-to-reach areas in the colon, the overtube kept the scope in place over half the time without slipping. This could lead to fewer complications during the procedure. Overall, the evidence so far indicates that the overtube is safe to use, with no major negative effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Pathfinder Endoscope Overtube because it introduces a new approach to performing endoscopic submucosal dissection (ESD) for gastrointestinal cancer. Unlike traditional ESD techniques, which rely on manually maneuvering the endoscope, this novel overtube potentially offers enhanced stability and precision during procedures. By stiffening the endoscope, the overtube aims to improve the accuracy of tumor removal, reduce procedure times, and minimize complications, offering a promising advancement in the treatment of gastrointestinal cancers.

What evidence suggests that the Pathfinder Endoscope Overtube is effective for gastrointestinal cancer?

In this trial, participants in the treatment arm will undergo endoscopic submucosal dissection using the Pathfinder Endoscope Overtube. Research has shown that new tools like the Pathfinder Endoscope Overtube can make endoscopic procedures quicker and more stable. Studies have found that this overtube greatly improves the steadiness of the scope, with one study showing 63.6% stability compared to just 24.2% without it. This increased control can reduce the time needed to complete procedures. Additionally, the overtube successfully kept the scope in place during challenging procedures about 55% of the time. Overall, the success rate of using these overtubes in clinical settings is impressively high, at 94.7%. ^{1 2 4 6 7}

Who Is on the Research Team?

Mohamed O. Othman, MD

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

This trial is for individuals at least 22 years old needing a procedure called ESD for colon tumors. They must have specific types of lesions, like those with scars or certain large spreading tumors, and not be located in the sigmoid colon or rectum. Pregnant or nursing women cannot participate.

Inclusion Criteria

I am referred for a specific colon procedure due to my lesion's size or type.

I am 22 years old or older.

Patients can provide written informed consent

Exclusion Criteria

My cancer affects the appendix opening or the valve between the small and large intestines.

Patient refused and/or unable to provide written informed consent

Patient is a pregnant or nursing woman

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo colonic endoscopic submucosal dissection (ESD) with or without the Pathfinder Endoscope Overtube

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Endoscopic Submucosal Dissection
• Novel Rigidizing Overtube

Trial Overview

The study tests a new device called Pathfinder® Endoscope Overtube during ESD procedures against conventional methods. The aim is to see if this overtube can make the procedure quicker and safer by providing better control over the endoscope.

How Is the Trial Designed?

Group I: Treatment arm Experimental Treatment 2 Interventions

Will have endoscopic submucosal dissection performed with the use of the Pathfinder Endoscope Overtube.

Group II: Control arm Active Control 1 Intervention

Will have endoscopic submucosal dissection performed through conventional means (i.e. without the Pathfinder Endoscope Overtube).

Endoscopic Submucosal Dissection is already approved in United States for the following indications:

Approved in United States as Pathfinder Endoscope Overtube for:

• Facilitate intubation, change of endoscopes, and treatment in the gastrointestinal (GI) tract in adult patients (22 years of age and older)

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Neptune Medical, Inc.

Collaborator

Trials

1

Recruited

70+

Published Research Related to This Trial

The newly developed inverted overtube significantly shortens hemostatic time and improves visibility during emergency endoscopic hemostasis, enhancing the overall effectiveness of the procedure.

Using this device during gastric endoscopic submucosal dissection (ESD) allows for safer operations by optimizing the angle and distance between the electric knife and the gastric mucosa, reducing risks during cutting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An effective and safe gastric endoscopic submucosal dissection in the right lateral position using an inverted overtube. Mori, H., Rafiq, K., Kobara, H., et al.[2021]

In a study involving 14 farm swine, the self-approximating translumenal access technique (STAT) successfully created directed submucosal tunnels for peroral transgastric peritoneoscopy, achieving access to predetermined abdominal locations in 12 out of 14 animals.

The procedure demonstrated safety, with no gastrotomy leaks observed post-operation, and a high short-term survival rate, as the animals recovered well and gained weight after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Directed submucosal tunneling permits in-line endoscope positioning for transgastric natural orifice translumenal endoscopic surgery (NOTES). Pauli, EM., Haluck, RS., Ionescu, AM., et al.[2021]

In a study of 50 patients, endoscopic submucosal dissection of gastric submucosal tumors (SMTs) was found to be effective, with complete resection of all tumors and no recurrence in 48 patients followed for one year.

The procedure had a manageable safety profile, with a 10% rate of perforation that was successfully treated, and no delayed complications reported, indicating that this method is a viable option for treating gastric SMTs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Preliminary experience with endoscopic gastric submucosal tumor resection through the submucosal tunnel using double tunnel and double flex endoscope]. Xiong, Y., Hu, H., Wang, A., et al.[2018]

In a study of 45 patients undergoing colorectal endoscopic submucosal dissection (ESD), the use of a balloon overtube significantly improved access and manipulation of the gastroscope, achieving an en bloc excision rate of 86.7% in challenging cases.

Overall, the en bloc excision rate for colorectal ESD was high at 95.6%, indicating that the balloon overtube is a useful tool for enhancing procedural success without increasing complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Balloon overtube-guided colorectal endoscopic submucosal dissection. Ohya, T., Ohata, K., Sumiyama, K., et al.[2021]

Endoscopic submucosal dissection (ESD) demonstrated a high en bloc resection rate of 91.5% and a tumor-free margin rate of 70.5% in 200 colorectal neoplasms, indicating its efficacy in treating these lesions.

While ESD is generally safe, with a low complication rate (1% requiring emergency procedures), the study suggests that for certain large or fibrotic neoplasms, alternative methods like piecemeal resection may be more suitable due to associated risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of endoscopic submucosal dissection for colorectal epithelial neoplasms in 200 consecutive cases. Fujishiro, M., Yahagi, N., Kakushima, N., et al.[2022]

The study introduces a combination of a dynamic rigidizing overtube and a novel injectable needle-type knife designed to improve the efficiency of colorectal endoscopic submucosal dissection.

This innovative approach aims to enhance the safety and efficacy of the dissection process, potentially leading to better outcomes in colorectal procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination of a dynamic rigidizing overtube and a novel injectable needle-type knife to facilitate colorectal endoscopic submucosal dissection. Coronel, M., Coronel, E., Romero, L., et al.[2021]

The new overtube device designed for endoscopic submucosal dissection (ESD) significantly increased the speed of the procedure, achieving a resection rate of 0.45 cm²/min compared to 0.22 cm²/min for conventional ESD, indicating greater efficacy.

The study, which involved 12 ESDs performed on six pigs, demonstrated that the overtube-assisted technique is feasible and may improve the effectiveness of endoscopic procedures with minimal adverse effects, as only one was noted in the conventional group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new 3D-printed overtube system for endoscopic submucosal dissection: first results of a randomized study in a porcine model. Zizer, E., Roppenecker, D., Helmes, F., et al.[2017]

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/pii/S294970862500010X

A systematic review of the clinical effectiveness of a novel ...

The overall clinical success was 94.7%. Procedure facilitation was reported in 3 studies, with an average of 92.5% facilitation. One study compared endoscopic ...

2.

igiejournal.org

igiejournal.org/article/S2949-7086(25)00010-X/pdf

A systematic review of the clinical effectiveness of a novel ...

In this study, we conducted a system- atic review to assess the clinical success of a rigidizing overtube (ROT) to facilitate completion of difficult.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06134687

Novel Rigidizing Overtube in Colonic Endoscopic ...

For polyps in difficult locations, the rigidizing overtube was able to maintain scope position without falling back even once, 55% of the time. This result was ...

4.

withpower.com

withpower.com/trial/phase-gastrointestinal-neoplasms-2024-a2419

Novel Rigidizing Overtube for Gastrointestinal Cancer

In a study of 45 patients undergoing colorectal endoscopic submucosal dissection (ESD), the use of a balloon overtube significantly improved access and ...

5.

journals.lww.com

journals.lww.com/ajg/fulltext/2025/10002/s2179_rigidizing_the_path_to_precision__a.2179.aspx

S2179 Rigidizing the Path to Precision: A Randomized ...

The rigidizing overtube significantly improved scope stability (O: 63.6% vs C: 24.2%, P = 0.003) and retroflexion capability (O: 69.7% vs C: 51.5%, P = 0.028).

6.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT06134687/novel-rigidizing-overtube-in-colonic-endoscopic-submucosal-dissection

Novel Rigidizing Overtube in Colonic Endoscopic ...

For polyps in difficult locations, the rigidizing overtube was able to maintain scope position without falling back even once, 55% of the time.

7.

giejournal.org

giejournal.org/article/S0016-5107(20)32022-8/fulltext

Sa2007 NOVEL RIGIDIZING OVERTUBE FOR ...

A novel rigidizing overtube suggests that it is useful in a variety of clinical scenarios including incomplete colonoscopy with standard instruments.