Traction Device for Digestive System Tumors

Recruiting at 1 trial location

Overseen By Michael Mercado, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Disqualifiers: Pregnancy, Pedunculated lesions, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new tool that might simplify and speed up the removal of certain colon tumors. Researchers aim to determine if a traction device (also known as a clip-assisted traction device) used during endoscopic submucosal dissection—a type of non-surgical tumor removal—is more effective than the traditional method. Individuals referred for this procedure due to specific types of colon tumors, such as those with scars or certain sizes, might be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance future treatment options.

Do I have to stop taking my current medications for the trial?

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 this traction device is safe for colonic endoscopic submucosal dissection?

Previous studies have shown that using traction devices during endoscopic submucosal dissection (ESD) is safe. For example, one study found that a clip and rubber band traction device was safer and more effective than traditional ESD for treating growths in the colon. Another study reported that the S-O clip, a specific traction device, was used in 27 procedures without any problems. These findings suggest that traction devices are generally well-tolerated during procedures like ESD, with no serious issues reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to enhance Endoscopic Submucosal Dissection (ESD) for treating digestive system tumors. The use of a traction device during ESD is the key difference here. Unlike traditional ESD, which can be challenging due to limited visibility and maneuverability, the traction device helps by providing better access and visibility to the lesion. This potentially makes the procedure more efficient and less risky, leading to better outcomes for patients.

What evidence suggests that this traction device is effective for colonic endoscopic submucosal dissection?

This trial will compare endoscopic submucosal dissection (ESD) with and without a traction device. Research has shown that using a traction device during ESD can enhance the procedure's safety and effectiveness for removing colon growths. One study found that a clip and rubber band traction device improved both safety and effectiveness. Another study highlighted that a helix tack suture device enhanced ESD results for colon and stomach procedures. Additionally, a multi-loop traction device led to faster procedures with fewer complications. Overall, these findings suggest that traction devices can make ESD quicker and safer. ^{1 3 6 7 8}

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 adults over 18 who need an ESD procedure for colonic neoplastic lesions. They must be able to consent and have specific types of lesions, including those with scars or certain sizes. It's not for pregnant women, minors, or patients with pedunculated lesions or those near the appendix or ileocecal valve.

Inclusion Criteria

Patient is referred for ESD procedure of colonic neoplastic lesions and with one of the following criteria: A- Lesions with prior resection or with scar at any size. B- Granular lateral spreading tumors (GLST) more than 3 cm. C- Non granular lateral spreading tumors (NGLST) more than 20 mm. D- Any suspected submucosal invasion such as Paris classification II a +II or lesions with positive non lifting sign.

Patients can provide informed consent.

Exclusion Criteria

My lesion is pedunculated.

Patient is a pregnant woman.

I have lesions on my appendix or ileocecal valve.

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 use of a traction device

1 day

1 visit (in-person)

Follow-up

Participants are monitored for post-procedural adverse events and abdominal pain

1 month

Follow-up visits as needed

What Are the Treatments Tested in This Trial?

Interventions

• Endoscopic Submucosal Dissection
• Traction Device

Trial Overview The study at Baylor St. Luke's Medical Center is testing if using a traction device during colonic ESD can make the procedure faster and more effective compared to the standard method without traction.

How Is the Trial Designed?

Group I: ESD with traction device Experimental Treatment 2 Interventions

ESD of target lesion will be performed with the assistance of a traction device.

Group II: Control arm Active Control 1 Intervention

ESD of target lesion will be performed without the use of a traction device

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+

Micro-Tech Endoscopy USA

Collaborator

Trials

1

Recruited

150+

Published Research Related to This Trial

The S-O clip-assisted endoscopic submucosal dissection (ESD) was found to be safe and effective, successfully resecting all 27 tumors without complications, while the conventional ESD group had one micro perforation that did not require further treatment.

The procedure time for S-O clip-assisted ESD was significantly shorter (37.4 minutes) compared to conventional ESD (67.1 minutes), indicating that this new traction device can enhance the efficiency of tumor removal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective clinical trial of traction device-assisted endoscopic submucosal dissection of large superficial colorectal tumors using the S-O clip. Ritsuno, H., Sakamoto, N., Osada, T., et al.[2022]

The study introduces a novel dual-action traction device designed to improve the effectiveness of endoscopic submucosal dissection, a procedure used to remove tumors from the gastrointestinal tract.

This innovative device aims to enhance the precision and safety of the dissection process, potentially leading to better patient outcomes during gastrointestinal surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a novel dual-action traction device to facilitate endoscopic submucosal dissection. Jawaid, S., Othman, M., Keihanian, T., et al.[2023]

A new traction device for endoscopic submucosal dissection (ESD) was developed, which is noninvasive and allows for a bilateral approach, showing no harmful effects on the body.

In a study of 37 patients, the device significantly reduced dissection times compared to a control group, with times decreasing from 5.8 to 2.1 minutes/cm² for easy cases and from 7.9 to 3.6 minutes/cm² for difficult cases, indicating its efficacy in facilitating rapid ESD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and clinical usability of a new traction device "medical ring" for endoscopic submucosal dissection of early gastric cancer. Matsumoto, K., Nagahara, A., Ueyama, H., et al.[2021]

The EndoTrac device demonstrated a 100% procedural success rate across various gastrointestinal neoplasms, indicating its effectiveness in facilitating endoscopic submucosal dissection (ESD).

Preparation times for ESD using the EndoTrac were relatively short, ranging from 2 to 6 minutes depending on the location of the lesions, suggesting that the device enhances the efficiency of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic Submucosal Dissection Using EndoTrac, a Novel Traction Device. Kaku, H., Toyonaga, T., Tanaka, S., et al.[2021]

The traction ring-assisted endoscopic submucosal dissection (ESD) demonstrated a high en bloc resection rate of 95% and an R0 resection rate of 90% in a pilot study involving 20 patients, indicating its efficacy in removing colorectal lesions.

The method was found to be safe, with no significant intraoperative bleeding and only one case of perforation that did not require further intervention, suggesting that the traction ring can be effectively used across various locations in the colorectum.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New traction method (traction ring) for colorectal endoscopic submucosal dissection. Huang, XY., Ji, M., Li, P., et al.[2022]

This multicenter randomized controlled trial will assess the effectiveness of S-O clips in colorectal endoscopic submucosal dissection (ESD) by enrolling 200 patients across 4 hospitals in Japan, focusing on procedure time and complication rates.

Using S-O clips is expected to make ESD easier and safer by improving visualization of the submucosal layer, potentially leading to shorter procedure times and fewer complications compared to conventional ESD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter randomized control study of the efficacy of SO clip in colorectal endoscopic submucosal dissection (ESD). (SO clip study in colorectal ESD): Randomized controlled trial. Taki, S., Iguchi, M., Fukatsu, K., et al.[2023]

The novel articulating traction device is designed to enhance the effectiveness of gastric and colonic endoscopic submucosal dissection procedures, potentially improving surgical outcomes.

This device allows for better manipulation and visibility during procedures, which may lead to safer and more efficient removal of lesions in the gastrointestinal tract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel articulating through-the-scope traction device. Simsek, C., Thompson, CC., Alkhateeb, KJ., et al.[2022]

The study evaluated the use of a snare combined with endoclips for mucosal traction during endoscopic submucosal dissection (SC-ESD) in 54 patients with gastroesophageal neoplasias, achieving a 100% complete resection rate without significant complications.

SC-ESD allowed for effective real-time adjustment of mucosal traction, demonstrating the feasibility of both peroral external traction (PET) and peroral internal traction (PIT) in enhancing the dissection process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Snare combined with endoclips in endoscopic submucosal dissection with mucosal traction for gastroesophageal neoplasia. Zhang, Q., Yao, X., Cai, JQ., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9613568/

Effectiveness of a novel traction device in endoscopic ... Compared with traditional ESD, CRT-ESD with clip and rubber band is both safer and more effective in the treatment of colorectal lesions.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06747988

Feasibility and Prospective Study of a Dynamic Traction ... We looked to investigate the efficacy and safety of using the novel TTS helix tack suture device as a dynamic traction device during colon and gastric ESD.

3. ales.amegroups.org ales.amegroups.org/article/view/10687/html

Traction methods in endoscopic submucosal dissection This review aims to evaluate various traction techniques and devices to provide surgical endoscopists with comprehensive options for effective ESD performance.

4. nature.com nature.com/articles/s41598-023-47390-4

The efficacy and safety of multi-loop traction device for ... Gastric ESD with the MLTD showed a favorable procedure time and dissection speed and an acceptable complication rate. Hence, the MLTD may be effective for ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0016510724001482

Endoscopic submucosal dissection with adaptive traction ... This prospective evaluation confirms the efficacy and safety of the adaptive traction strategy with the ATRACT device for colorectal ESD with high resection ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06747988

Feasibility and Prospective Study of a Dynamic Traction ... We looked to investigate the efficacy and safety of using the novel TTS helix tack suture device as a dynamic traction device during colon and gastric ESD.

7. withpower.com withpower.com/trial/phase-neoplasms-gastrointestinal-10-2023-a660f

Traction Device for Digestive System Tumors The S-O clip-assisted endoscopic submucosal dissection (ESD) was found to be safe and effective, successfully resecting all 27 tumors without complications, ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10089768/

A new traction device (S-O clip) facilitating the endoscopic ... An SO clip has been developed to simplify the attachment procedure, eliminating interference with the endoscope and improving accessibility.