NCT03626194

Recruiting

Prospective Evaluation of the Efficacy and Safety of Endosco...

University of Colorado, Denver Source

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Other study identifiers

Sponsor study identifier

16-1826

Study Type

observational

Estimated enrollment

500

Locations

1 country

Sites

1

Timeline

Study Start

December 12, 2016

Actual (reported)

Primary Completion

December 16, 2025

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

December 16, 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Brief 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: recruiting
Estimated enrollment: 500 participants
Study completion date: December 16, 2026
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
December 12, 2016
Actual (reported)
First Submitted
August 2, 2018
Actual (reported)
First Posted
August 10, 2018
Actual (reported)
Primary Completion
December 16, 2025
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 16, 2026
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated: May 21, 2024
Status Verified: May 2024
Last Update Submitted: May 20, 2024

Conditions

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

Outcome Measures

Primary Outcomes (2)

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..
From baseline to one year
Adverse Events
Based on ASGE criteria
From baseline to one year

Eligibility Criteria

Age18 Years - 89 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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.

You may qualify if:

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

Sponsors & Collaborators

University of Colorado, Denver
Otherlead

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

RECRUITING

Abigail LoweCONTACT303-724-6070 ABIGAIL.LOWE@UCDENVER.EDU

Mihir Wagh, MDPRINCIPAL INVESTIGATOR

Central Study Contacts

Abigail Lowe

CONTACT

303-724-6070 ABIGAIL.LOWE@UCDENVER.EDU

Study Design

Study Type: observational
Observational Model: OTHER
Time Perspective: PROSPECTIVE
Target Duration: 2 Years
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 2, 2018

First Posted

August 10, 2018

Study Start

December 12, 2016

Actual (reported)

Primary Completion

December 16, 2025

Estimated (date passed)

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

December 16, 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated

May 21, 2024

Record last verified: 2024-05

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT03626194
Data provider: ClinicalTrials.gov
Source updated: 2024-05-21
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:35:36 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations