Stent MigrationNCT05081752
Preventing Esophageal Stent Migration in Esophageal Strictures
A study testing OTSC Stentfix and Stent Suturing / Endoscopic Clips in people with Stent Migration, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stent Migration
- What is being tested?
- OTSC Stentfix and Stent Suturing / Endoscopic Clips
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2023to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 1. Patients who have strictures treated with luman apposing stents.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of no Fixation vs. Stent Suturing vs. OTSC Stentfix in Preventing Esophageal Stent Migration in Esophageal Strictures
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.
- Conditions
- Stent Migration
- Being tested
- OTSC Stentfix, Stent Suturing / Endoscopic Clips
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTSC StentfixDevice
Stent placement with fixation of the esophageal stent using OTSC Stentfix.
Stent Suturing / Endoscopic ClipsProcedure or surgery
Stent placement with fixation of the esophageal stent using sutures / endoscopic clips.
| Study group | Role | What they receive |
|---|---|---|
| No fixation | No intervention | Not described |
| Stent Suturing | Active comparator | Not described Receives: Procedure: Stent Suturing / Endoscopic Clips |
| OTSC Stentfix | Experimental | Not described Receives: Device: OTSC Stentfix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants who Experience Stent Migration
Measured: Week 48
Secondary outcomes (2)
Total Procedural Time
Time it takes to complete standard of care upper endoscopy with standard of care stent placement with or without fixation.
Measured: 120 minutes
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.
Measured: Baseline, Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study startFeb 2023 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2025 (estimated)
Why it stopped: Difficulties in recruiting and lack of interest from care providers.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stent MigrationStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory Haber, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05081752
- Sponsor's protocol ID
- 20-01901
- Status last verified
- Apr 2023
- First submitted
- 30 Sep 2021
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of no Fixation vs. Stent Suturing vs. OTSC Stentfix in Preventing Esophageal Stent Migration in Esophageal Strictures
- ClinicalTrials.gov ID
- NCT05081752
- Acronym / sponsor ID
- 20-01901
- Conditions
- Stent Migration
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulties in recruiting and lack of interest from care providers.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 18 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No fixation | No intervention | – |
| Stent Suturing | Active comparator | Procedure: Stent Suturing / Endoscopic Clips |
| OTSC Stentfix | Experimental | Device: OTSC Stentfix |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. Patients who have strictures treated with luman apposing stents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OTSC StentfixStent placement with fixation of the esophageal stent using OTSC Stentfix. | Device | OTSC Stentfix |
| Stent Suturing / Endoscopic ClipsStent placement with fixation of the esophageal stent using sutures / endoscopic clips. | Procedure or surgery | Stent Suturing |
Primary outcome
Number of Participants who Experience Stent Migration
Time frame: Week 48
2 secondary outcomes
Total Procedural Time
Time frame: 120 minutes
Change in Score on Dysphagia Outcome and Severity Scale (DOSS)
Time frame: Baseline, Week 48
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Haber, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OTSC Stentfix and Stent Suturing / Endoscopic Clips in people with Stent Migration, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants who Experience Stent Migration (time frame: Week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2023.