Preventing Esophageal Stent Migration in Esophageal Stric... | NCT05081752

Studies
Preventing Esophageal Stent Migration in Esophageal Strictures

NCT05081752

Sponsor

NYU Langone Health

Status

Withdrawn

Last Update Posted

Apr 10, 2023Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Stent Migration

Interventions

OTSC Stentfix
Stent Suturing / Endoscopic Clips

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficulties in recruiting and lack of interest from care providers.

Expanded Access Info

Start Date

Feb 2023Estimated

Primary Completion Date

Sep 30, 2024Estimated

Completion Date

Sep 30, 2025Estimated

First Submitted Date

Sep 30, 2021

First Submission Date that Met QC Criteria

Oct 13, 2021

First Posted Date

Oct 18, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2023

Last Update Posted Date

Apr 10, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
No fixation	No Intervention
Stent Suturing	Active Comparator	Procedure: Stent Suturing / Endoscopic Clips
OTSC Stentfix	Experimental	Device: OTSC Stentfix

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OTSC Stentfix	Device	Stent placement with fixation of the esophageal stent using OTSC Stentfix.	OTSC Stentfix

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants who Experience Stent Migration		Week 48

Secondary Outcomes

Measure	Description	Time Frame
Total Procedural Time	Time it takes to complete standard of care upper endoscopy with standard of care stent placement with or without fixation.	120 minutes
Change in Score on Dysphagia Outcome and Severity Scale (DOSS)

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gregory Haber, MD	NYU Langone Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NYU Langone Health		New York	New York	10016	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

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.

Types

Study Protocol
Statistical Analysis Plan (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.

URL

Not provided