Utility of OverStitch Sx After ESD

NCT04361227 | Completed DMC

• 1 other identifier: H-47184
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective study where the investigators will make a database of all the patients who have received this procedure and will document various outcomes (i.e. number of sutures used, number of clips (if used), time required to close, complications/ issues). No changes will be done to the participant's procedure and the participants are asked to consent for the use of the participant's data in our database. The participants are being asked to be in this research study because the participants have been scheduled to undergo an ESD procedure at Baylor St. Luke Medical Center and will most likely require clipping and/or suturing following intervention. This study is important because this is a relatively new procedure; although it is a part of the participant's standard of care, it is not done in many hospitals. The investigators would like to document the outcomes and results of such procedures to continuously improve our standard of care.

Conditions

Gastrointestinal Neoplasms

Keywords

Gastrointestinal Neoplasms; OverStitch Sx; Endoscopic Submucosal Dissection

Outcome Measures

Primary Outcomes (3)

• Clinical/technical success rate utilizing endosuture

  To assess feasibility and technical success of using Overstitch Sx system for closure after ESD

  2 years

• Rate of patients reported with bleeding/perforation post-ESD procedure

  Conduct follow-ups for risk of bleeding and perforation after closure

  2 years

• Closure time after ESD

  Record time needed to close lesion

  2 years

Secondary Outcomes (2)

• Additional clip closure

  2 years

• Clips used post-ESD

  2 years

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred to/scheduled for ESD procedure at Baylor College of Medicine with possible mucosal defect closure.

You may qualify if:

• Adults age 18-99, who are scheduled to undergo ESD procedure with possible mucosal defect closure.

You may not qualify if:

• Age is less than 18 years old

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Keihanian T, Zabad N, Khalaf M, Abdel-Jaber W, Kim YI, Jawaid SA, Abidi WM, Marginean EC, Othman MO. Safety and efficacy of a novel suturing device for closure of large defects after endoscopic submucosal dissection (with video). Gastrointest Endosc. 2023 Sep;98(3):381-391. doi: 10.1016/j.gie.2023.04.006. Epub 2023 Apr 14.

  PMID: 37061137 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Gastrointestinal lesion/biopsy for pathological evaluation

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 48 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: April 24, 2020
• Study Start: July 2, 2020
• Primary Completion: May 31, 2022
• Study Completion: October 20, 2022
• Last Updated: February 15, 2023

Record last verified: 2023-02

Locations

US (1)