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

Trial Summary

What is the purpose of this trial?

The goal of this prospective, single centre, 1:1, Post Market, randomized controlled, Investigator Initiated trial, is to compare the feasibility, safety efficacy, and clinical outcomes of colonic endoscopic submucosal dissection (ESD) utilizing a novel rigidizing overtube called Pathfinder® Endoscope Overtube (Neptune Medical, Burlingame California, USA) device in comparison to conventional ESD. The research team hypothesize that with utilizing a novel rigidizing overtube the procedure time including dissection speed and closure time will be faster due to higher scope stability and greater control over the scope tip. Subsequently, the investigators anticipate lower immediate or delayed adverse events.

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 data supports the effectiveness of the treatment Novel Rigidizing Overtube for Gastrointestinal Cancer?

Research shows that using a rigidizing overtube can help make endoscopic submucosal dissection (a procedure to remove cancerous tissue from the digestive tract) safer and more effective by improving the view and control during the procedure. This has been demonstrated in similar procedures for colorectal and gastric conditions. ^{1 2 3 4 5}

What makes the Novel Rigidizing Overtube treatment for gastrointestinal cancer unique?

The Novel Rigidizing Overtube treatment is unique because it uses a special tube that becomes rigid to help guide the endoscope during Endoscopic Submucosal Dissection (ESD), making the procedure more precise and potentially safer compared to traditional methods. This approach is different from standard treatments as it provides better control and stability during the procedure. ^{1 2 4 6 7}

Research Team

Mohamed O. Othman, MD

Principal Investigator

Baylor College of Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Combination of a dynamic rigidizing overtube and a novel injectable needle-type knife to facilitate colorectal endoscopic submucosal dissection. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Balloon overtube-guided colorectal endoscopic submucosal dissection. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

Directed submucosal tunneling permits in-line endoscope positioning for transgastric natural orifice translumenal endoscopic surgery (NOTES). [2021]

4. United States pubmed.ncbi.nlm.nih.gov

An effective and safe gastric endoscopic submucosal dissection in the right lateral position using an inverted overtube. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Outcomes of endoscopic submucosal dissection for colorectal epithelial neoplasms in 200 consecutive cases. [2022]

6. Germany 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. [2017]

7. China pubmed.ncbi.nlm.nih.gov

[Preliminary experience with endoscopic gastric submucosal tumor resection through the submucosal tunnel using double tunnel and double flex endoscope]. [2018]