Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05127408 |
| Other study ID # |
021.GID.2019.D |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 7, 2019 |
| Est. completion date |
April 14, 2021 |
Study information
| Verified date |
February 2022 |
| Source |
Methodist Health System |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
The purpose of this prospective registry is to assess long-term data on efficacy, safety and
clinical outcome of endoscopic placement of suture(s) and approximation of soft tissue within
the gastrointestinal tract for various GI tract disorders. Currently, lack enough data
evaluate and verify technical feasibility, clinical success and safety of endoscopic suturing
in specific gastrointestinal disorders.1-16 Evaluation of these factors would help us compare
them to conventional treatment modalities; and consequently help us identify appropriate
treatment techniques and improve clinical management of patients.
Description:
This study is a prospective, observational, medical chart review for at least six standards
of care visits up to 1 year after subject consents for study participation. There will be a
retrospective chart review for patients who underwent endoscopic suturing procedures from
October 2014 - April 2019. Those subjects will undergo no additional tests and procedures as
part of this study. All data will be collected from patient's electronic health records (EHR)
of the hospital In addition; a prospective chart review will be performed for patients who
will undergo endoscopic suturing procedures from April 2019 to April 2021. All the subjects
enrolled in prospective chart review will be first consented for their study participation.
Subjects will undergo a clinically indicated endoscopic suturing procedure and standard of
care follow up visits.
