Back to resultsPreventing Esophageal Stent Migration in Esophageal Strictures
Primary Purpose
Stent Migration
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OTSC Stentfix
Stent Suturing / Endoscopic Clips
Sponsored by
About this trial
This is an interventional treatment trial for Stent Migration
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
1. Patients who have strictures treated with luman apposing stents.
Sites / Locations
- NYU Langone Health
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Experimental
Arm Label
No fixation
Stent Suturing
OTSC Stentfix
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants who Experience Stent Migration
Secondary Outcome Measures
Total Procedural Time
Time it takes to complete standard of care upper endoscopy with standard of care stent placement with or without fixation.
Change in Score on Dysphagia Outcome and Severity Scale (DOSS)
DOSS is a simple, easy-to-use, 7-point scale developed to systematically rate the functional severity of dysphagia. The total range of score is 1-7; a lower score indicates more severe symptoms of dysphagia.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05081752
Brief Title
Preventing Esophageal Stent Migration in Esophageal Strictures
Official Title
Comparison of no Fixation vs. Stent Suturing vs. OTSC Stentfix in Preventing Esophageal Stent Migration in Esophageal Strictures
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Difficulties in recruiting and lack of interest from care providers.
Study Start Date
February 2023 (Anticipated)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stent Migration
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Subjects will be blinded as to which study arm they are in, in order to avoid any bias they may have.
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No fixation
Arm Type
No Intervention
Arm Title
Stent Suturing
Arm Type
Active Comparator
Arm Title
OTSC Stentfix
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
OTSC Stentfix
Intervention Description
Stent placement with fixation of the esophageal stent using OTSC Stentfix.
Intervention Type
Procedure
Intervention Name(s)
Stent Suturing / Endoscopic Clips
Intervention Description
Stent placement with fixation of the esophageal stent using sutures / endoscopic clips.
Primary Outcome Measure Information:
Title
Number of Participants who Experience Stent Migration
Time Frame
Week 48
Secondary Outcome Measure Information:
Title
Total Procedural Time
Description
Time it takes to complete standard of care upper endoscopy with standard of care stent placement with or without fixation.
Time Frame
120 minutes
Title
Change in Score on Dysphagia Outcome and Severity Scale (DOSS)
Description
DOSS is a simple, easy-to-use, 7-point scale developed to systematically rate the functional severity of dysphagia. The total range of score is 1-7; a lower score indicates more severe symptoms of dysphagia.
Time Frame
Baseline, Week 48
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
1. Patients who have strictures treated with luman apposing stents.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Haber, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
IPD Sharing 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.
IPD Sharing 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.
Learn more about this trial
Preventing Esophageal Stent Migration in Esophageal Strictures
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