Comparison of Stent Suturing Versus OTSC Stentfix

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-21

Study Completion Date

2025-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Esophageal Stent Fixation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Patients will be blinded as to which study arm they are in, in order to avoid any bias they may have.

Study Groups

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OTSC Stentfix

Group Type EXPERIMENTAL

OTSC Stentfix

Intervention Type DEVICE

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

Stent Suturing

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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OTSC Stentfix

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.