Status:
COMPLETED
Endoscopic Suturing (ES) Registry
Lead Sponsor:
American Gastroenterological Association
Collaborating Sponsors:
Apollo Endosurgery, Inc.
Conditions:
Surgery
Eligibility:
All Genders
18+ years
Brief Summary
To determine patient outcomes (survival, additional endoscopic or surgical procedures) with an endoscopic suturing technique at predetermined intervals compared to historical controls when applicable....
Detailed Description
To determine patient outcomes (survival, morbidity including hospitalization, additional re-interventions with radiologic, endoscopic or surgical procedures) with endoscopic suturing at predetermined ...
Eligibility Criteria
Inclusion
- Selected to undergo trans-orifice suturing prior to study enrollment
- Age 18+ years
- Patient ASA classification I, II, III, including emergency cases
- Patient willing to provide informed consent, cooperate with post-operative recommendations and follow-up assessment
Exclusion
- Patients who do not meet the clinical criteria for trans-orifice suturing
- Under age 18 years
- ASA classification IV
- Unable to provide informed consent
- Unable to participate in follow-up assessments
- Uncorrectable coagulopathy at the time of endoscopic suturing
- Any terminal disease that limits patient's survival to less than one year
Key Trial Info
Start Date :
October 29 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 30 2021
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT03776188
Start Date
October 29 2018
End Date
November 30 2021
Last Update
December 7 2021
Active Locations (11)
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1
University of Arkansas
Little Rock, Arkansas, United States, 72211
2
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
3
Borland Grover Clinic
Jacksonville, Florida, United States, 32256
4
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201