NCT05081752

Brief Summary

This study aims to assess the efficacy and rate of stent migration in standard of care esophageal stents that are not fixed, compared to those that are fixed with either standard of care OTSC stentfix or standard of care stent placement with suturing in both benign and malignant esophageal strictures.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 18, 2021

Completed
1.3 years until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

April 10, 2023

Status Verified

April 1, 2023

Enrollment Period

1.7 years

First QC Date

September 30, 2021

Last Update Submit

April 6, 2023

Conditions

Stent Migration

Outcome Measures

Primary Outcomes (1)

  • Number of Participants who Experience Stent Migration

    Week 48

Secondary Outcomes (2)

  • Total Procedural Time

    120 minutes

  • Change in Score on Dysphagia Outcome and Severity Scale (DOSS)

    Baseline, Week 48

Study Arms (3)

No fixation

NO INTERVENTION

Stent Suturing

ACTIVE COMPARATOR
Procedure: Stent Suturing / Endoscopic Clips

OTSC Stentfix

EXPERIMENTAL
Device: OTSC Stentfix

Interventions

OTSC StentfixDEVICE

Stent placement with fixation of the esophageal stent using OTSC Stentfix.

OTSC Stentfix
Stent Suturing / Endoscopic ClipsPROCEDURE

Stent placement with fixation of the esophageal stent using sutures / endoscopic clips.

Stent Suturing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The study population will include any adult (18 years +) who will undergo standard of care esophageal stent placement for benign or malignant esophageal strictures as either an inpatient or outpatient at NYULH.
  • The participant is able to consent to stent placements with fixation or without fixation and study procedures, verified by signature on the informed consent form.
  • Willing to comply with all study procedures and be available for the duration of the study.
  • English and Non-English speaking participants.

You may not qualify if:

  • \. Patients who have strictures treated with luman apposing stents.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Study Officials

  • Gregory Haber, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Subjects 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

September 30, 2021

First Posted

October 18, 2021

Study Start

February 1, 2023

Primary Completion

September 30, 2024

Study Completion

September 30, 2025

Last Updated

April 10, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.

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)