Comparison of Stent Suturing Versus OTSC Stentfix

NCT04936425 | Withdrawn DMC FDA Device

• 1 other identifier: 20-01140
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate whether OTSC stentfix is a feasible, safe, and efficient device that can be used for esophageal stent fixation (to prevent stent migration) in patients with benign, non-stricture esophageal lesions, including leaks, perforation, and fistulae. Currently, self-expandable metal stents (SEMS) have a risk of migration which can lead to adverse events such as bleeding and perforation. There has been clinical experience demonstrating that stent suturing can prevent stent migration. However, stent suturing can significantly increase endoscopic procedural time. The use of OTSC stentfix for stent fixation is promising as it is likely less time-consuming and less technically difficult, with likely a similar rate of fixation and migration. This non-inferiority study aims to investigate how OTSC stentfix functions as compared to stent suturing. If OTSC stentfix is at least comparable to stent suturing, it can reduce endoscopy procedural times, minimize peri-endoscopic risks, and minimize adverse events related to stent migration.

Conditions

Esophageal Stent Fixation

Outcome Measures

Primary Outcomes (1)

• Average rate of stent migration

  48 weeks

Secondary Outcomes (2)

• Procedural time needed for stent fixation

  120 minutes

• Duration of time until stent migration for stents that fail fixation

  48 weeks

Study Arms (2)

OTSC Stentfix

EXPERIMENTAL

Device: OTSC Stentfix

Stent Suturing

NO INTERVENTION

Interventions

OTSC Stentfix DEVICE

The OTSC stentfix will be placed during upper endoscopy after a self-expanding metal stent has been deployed.

OTSC Stentfix

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adults (18+ years)
• Have benign, non-stricture esophageal lesions (i.e. fistulae, perforation, leaks) warranting esophageal stent placement as an inpatient or outpatient
• Ability to consent to stent fixation.

You may not qualify if:

• \< 18 years old

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Study Officials

• Gregory Haber, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

• Lauren Khanna, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be blinded as to which study arm they are in, in order to avoid any bias they may have.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: June 23, 2021
• Study Start: July 21, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2025
• Last Updated: June 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research
• Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to sofia.yuen@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)