Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition

NCT ID: NCT03626194

Last Updated: 2024-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-12

Study Completion Date

2026-12-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is a prospective registry of patients undergoing endoscopic suturing and/or clip placement at our institution to assess the efficacy and safety of endoscopic tissue apposition.

1.1 Hypothesis: Endoscopic tissue apposition is efficacious and safe in the practice of gastrointestinal endoscopy.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endoscopic Tissue Apposition Endoscopic Suturing Endoscopic Clipping Bariatric Endoscopy Transoral Outlet Reduction Endoscopic Sleeve Gastroplasty

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients\>18 years of age undergoing endoscopy for any of the following indications:

Indications for Tissue Apposition:

* 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
* Closure of mucosotomy after Peroral Endoscopic Myotomy (POEM)
* Stent fixation
* Closure of fistulas
* Natural Orifice Transluminal Endoscopic Surgery defect closures
* Post-bariatric surgery gastrojejunal anastomosis and gastric pouch revision (transoral outlet repair)
* Primary endoscopic sleeve gastroplasty

Exclusion Criteria

* Patients unable or unwilling to provide consent
* Pregnant patients
* Coagulation disorders (INR \>1.8, platelet \<50,000)
* GI Bleeding
* Hemodynamic instability
* Enrollment in another device or drug study that may confound the results
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Colorado Hospital

Aurora, Colorado, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Abigail Lowe

Role: CONTACT

303-724-6070

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Abigail Lowe

Role: primary

303-724-6070

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

16-1826

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Endosleeve in Adolescents
NCT03778697 COMPLETED PHASE1/PHASE2