Gastrointestinal Tract Disorders: A Prospective Multicenter Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

58 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-07

Study Completion Date

2021-04-14

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Endoscopic Suturing GI Tract Disorders Gastrointestinal Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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Interventional Endoscopy

correct defects of the gastrointestinal tract.

Intervention Type PROCEDURE

Other Intervention Names

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Apollo Endosurgery OverStitch™ Endoscopic Suture System (ESS) (or Endo Stitch™ , the SILS™ Stitch)

Eligibility Criteria

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Inclusion Criteria

* Any patient who has undergone clinically indicated and/or standard of care endoscopic suturing within the Gastrointestinal tract
* Above or equal to 18 years of age