CClinicalTrials.gg
Sign In
RecruitingNCT03626194Updated May 21, 2024

Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition

An observational study in Endoscopic Tissue Apposition, Endoscopic Suturing and Endoscopic Clipping, sponsored by University of Colorado, Denver. Recruiting at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2024-05-21.

Sponsored by University of Colorado, Denver · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Dec 2016; still recruiting 9 years 9 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
500
Ages
18 Years to 89 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Endoscopic Tissue Apposition
  • Endoscopic Suturing
  • Endoscopic Clipping
  • Bariatric Endoscopy
  • Transoral Outlet Reduction
  • Endoscopic Sleeve Gastroplasty
03

In context

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.

Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

A prospective database/registry of patients undergoing endoscopic tissue apposition will be formed. Women and minorities will be included as they are frequently found to have indications for which endoscopic tissue apposition may be indicated.

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

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
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
500 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Technical and clinical success in endoscopic tissue apposition

    Successful completion of endoscopic suturing/clipping and measured as clinical symptom improvement as well as objective evidence of resolution / improvement of underlying pathology / confirmed with radiologic contrast studies as needed..

    Time frame: From baseline to one year

  2. Adverse Events

    Based on ASGE criteria

    Time frame: From baseline to one year

07

Study locations

1 of 1 sites recruiting
  • University of Colorado Hospital
    Aurora, Colorado 80045, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03626194
Lead sponsor
University of Colorado, Denver
Responsible party
Sponsor
First posted
Aug 10, 2018
Start date
Dec 12, 2016
Primary completion
Dec 16, 2025 (estimated)
Completion
Dec 16, 2026 (estimated)
Last update
May 21, 2024

Study contacts

Abigail Lowe
Contact
ABIGAIL.LOWE@UCDENVER.EDU
303-724-6070

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

University of Colorado, Denver

Start the discussion