Endoscopic Tissue Apposition for Gastrointestinal Endoscopy

Overseen By Abigail Lowe

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Pregnancy, Coagulation disorders, GI bleeding, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Baseline to one year

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment technique called endoscopic tissue apposition, used to close openings or defects in the digestive tract. Researchers aim to determine if this method is both effective and safe for patients requiring procedures such as perforation closures or repairs after certain surgeries. Suitable candidates for this trial include those who have recently undergone an endoscopy for issues like fistulas or need repairs following bariatric surgery. Participants should not have bleeding problems or be involved in another study that might affect this one. As a Phase 3 trial, this treatment is in the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking medical advancement.

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 endoscopic tissue apposition is safe for gastrointestinal endoscopy?

Research has shown that endoscopic tissue apposition is generally safe. For instance, a new clip with small anchor prongs was tested and proved safe for closing openings or tears inside the body. Another study found that special medical tools, such as forceps, were safe for closing large tissue openings. However, not all studies provide specific safety data for use in the digestive system. Still, other studies have reviewed the technique and suggest it is usually well-tolerated.

In summary, based on available research, the treatment is mostly considered safe. Reports indicate it is effective and carries a low risk of complications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Endoscopic Tissue Apposition is unique because it uses a minimally invasive technique to close tissue without the need for traditional surgery. Most treatments for tissue repair involve surgical procedures, which can be more invasive and require longer recovery times. This method allows for quicker recovery and potentially fewer complications, as it reduces the physical impact on the body. Researchers are excited about this technique because it offers a safer and more efficient alternative to conventional surgical options.

What evidence suggests that endoscopic tissue apposition is effective for gastrointestinal endoscopy?

Studies have shown that endoscopic methods effectively close large openings in the digestive tract. One research study demonstrated that special devices successfully closed these openings. Another study found that a specific type of clip achieved success in 89.1% of cases, leading to health improvements in 85.2% of patients. Early experiences with these devices also showed success in about 89% of patients. These findings suggest that endoscopic methods offer a promising approach to improving digestive procedures. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

Inclusion Criteria

Closure of perforations

Closure of full thickness defects created during endoscopic full thickness resection

Closure of defects after endoscopic submucosal dissection and endoscopic mucosal resection

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo endoscopic suturing and/or clip placement to assess efficacy and safety

Baseline to one year

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to one year

What Are the Treatments Tested in This Trial?

Interventions

• Endoscopic Tissue Apposition

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40640617/

RCT comparing the clinical efficacy and costs of two tissue ... In this RCT, both TTS approximation devices equally facilitated approximation/closure of large ERD. Approximation with the DAT clip was ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1521691824000374

Endoscopic suturing and clipping devices for defects in the ... OTSC was successfully deployed at a rate of 89.1 % (95%CI: 81.6%–93.8 %; I2 = 41.06 %) and clinical improvement was recorded in 85.2 % (95%CI: 71.9%–92.8 %, I2 ...

3. journals.lww.com journals.lww.com/ajg/fulltext/2023/10001/s1210_randomized_controlled_trial_comparing_the.2028.aspx

Official journal of the American College of Gastroenterology In this study we compare the clinical efficacy and cost of 2 novel through the scope (TTS) tissue approximation devices in the management of large ERD.

4. ctv.veeva.com ctv.veeva.com/study/prospective-evaluation-of-the-efficacy-and-safety-of-endoscopic-tissue-apposition

Prospective Evaluation of the Efficacy and Safety of ... 1.2 Aims: To prospectively evaluate the efficacy and safety of Endoscopic Tissue Apposition in the practice of gastrointestinal endoscopy.

5. giejournal.org giejournal.org/article/S0016-5107(21)01730-2/fulltext

Initial multicenter experience using a novel endoscopic ... Technical success of the intended use of the device was achieved in 83 patients (89.2%). Closure was partially successful in 8 patients (8.6%), ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11192586/

A new through-the-scope clip with anchor prongs is safe ... A novel TTSC with anchor prongs showed success in a range of defect closures, an acceptable safety profile, and low incidence of technical difficulties.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2949708625000068

Efficacy and safety of a multi-degree-of-freedom ... The MDOF articulating forceps seem to be an effective and safe adjunct traction tool for ESD and closure of large mucosal defects.

8. asge.org asge.org/docs/default-source/education/Technology_Reviews/doc-71b1f624-8039-486a-8fae-3886b9745e15.pdf

Endoscopic closure devices Safety data are not available for GI applications of the ... Endoscopic closure of gastro- gastric fistulae by using a tissue apposition system (with videos).

9. e-ce.org e-ce.org/journal/view.php?number=7078

Endoscopic Suturing for Large Submucosal and Full- ... Abstract. This article is a systematic review of relevant literature on endoscopic suturing as a primary closure technique for large ...

10. giejournal.org giejournal.org/article/S0016-5107(23)02831-6/fulltext

New endoscopic closure technique, “internal traction– ... Data from patients in whom this suspended closure technique was used to close full-thickness defects after EFTR were retrospectively reviewed.