Endoscopic Tissue AppositionNCT03626194
Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition
An observational study of Endoscopic Tissue Apposition and Endoscopic Suturing, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Endoscopic Tissue Apposition, Endoscopic Suturing, Endoscopic Clipping
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2016to 16 Dec 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Hospital
Aurora, Colorado, 80045
Abigail Lowe, 303-724-6070, ABIGAIL.LOWE@UCDENVER.EDU
Mihir Wagh, MD
About this study
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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..
Measured: From baseline to one year
Adverse Events
Based on ASGE criteria
Measured: From baseline to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start12 Dec 2016
- Primary completion16 Dec 2025 (estimated)
- Study completion16 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopic Tissue AppositionStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03626194
- Sponsor's protocol ID
- 16-1826
- Status last verified
- May 2024
- First submitted
- 2 Aug 2018
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition
- ClinicalTrials.gov ID
- NCT03626194
- Acronym / sponsor ID
- 16-1826
- Conditions
- Endoscopic Tissue Apposition, Endoscopic Suturing, Endoscopic Clipping, Bariatric Endoscopy, Transoral Outlet Reduction, Endoscopic Sleeve Gastroplasty
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 12 Dec 2016 (actual)
- Primary completion
- 16 Dec 2025 (estimated)
- Study completion
- 16 Dec 2026 (estimated)
- First posted
- 10 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- Patients>18 years of age undergoing endoscopy for any of the following indications:
- 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)
Key exclusion criteria (6 listed)
- Patients unable or unwilling to provide consent
- Pregnant patients
- Coagulation disorders (INR >1.8, platelet <50,000)
- GI Bleeding
- Hemodynamic instability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Technical and clinical success in endoscopic tissue apposition
Time frame: From baseline to one year
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..
Adverse Events
Time frame: From baseline to one year
Based on ASGE criteria
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endoscopic Tissue Apposition and Endoscopic Suturing, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abigail Lowe (303-724-6070, ABIGAIL.LOWE@UCDENVER.EDU), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical and clinical success in endoscopic tissue apposition (time frame: From baseline to one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.