Comparison of Stent Suturing Versus OTSC Stentfix

Comparison of Stent Suturing Versus OTSC Stentfix in Preventing Esophageal Stent Migration in Non-Stricture Esophageal Lesions

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04936425

Enrollment

Registered

2021-06-23

Start date

2023-07-21

Completion date

2025-07-31

Last updated

2023-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Stent Fixation

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.

Interventions

DEVICEOTSC Stentfix

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Masking description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Exclusion criteria

* \< 18 years old

Design outcomes

Primary

Measure	Time frame
Average rate of stent migration	48 weeks

Secondary

Measure	Time frame
Procedural time needed for stent fixation	120 minutes
Duration of time until stent migration for stents that fail fixation	48 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026