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Device

OTSC Stentfix for Esophageal Stent Fixation

N/A
Waitlist Available
Led By Gregory Haber, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 120 minutes
Awards & highlights

Study Summary

This trial is testing a new device, OTSC stentfix, to see if it is a safe and efficient way to keep esophageal stents in place in patients with benign lesions. The device may be less time-consuming and less technically difficult than the current standard of care, stent suturing, and may reduce endoscopy procedural times and minimize peri-endoscopic risks and adverse events related to stent migration.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~120 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 120 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Average rate of stent migration
Secondary outcome measures
Duration of time until stent migration for stents that fail fixation
Procedural time needed for stent fixation

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: OTSC StentfixExperimental Treatment1 Intervention
Group II: Stent SuturingActive Control1 Intervention

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,366 Previous Clinical Trials
839,661 Total Patients Enrolled
Gregory Haber, MDPrincipal InvestigatorNYU Langone Health
3 Previous Clinical Trials
223 Total Patients Enrolled
Lauren Khanna, MDPrincipal InvestigatorNYU Langone Health

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this study still taking place?

"According to the details on clinicaltrials.gov, this study has ceased recruitment of participants as its initial post date was July 21st 2023 and it was last updated July 21st 2022. However, there are still 1 other trials actively looking for patients at present."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Comparison of Stent Suturing Versus OTSC Stentfix
2023. "Comparison of Stent Suturing Versus OTSC Stentfix". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04936425.
~0 spots leftby Jul 2024
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