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Suture fixation of stent for Esophageal Cancer

N/A

Recruiting

Led By Shailendra Singh

Research Sponsored by West Virginia University

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 3 months

Awards & highlights

Study Summary

This trial is testing whether suture fixation of esophageal stents is superior to non-suture fixated stent placement.

Eligible Conditions

Esophageal Cancer
Esophageal Dysphagia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Composite of stent migration or total stent dislodgement

Secondary outcome measures

Adverse events

Length of procedure

Stent, device

+2 more

Other outcome measures

Cost of procedure

Dysphagia

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Suture armExperimental Treatment1 Intervention

Esophageal stent will be placed in standard of care fashion by the endoscopists using standard gastroscopes. After esophageal stent placement, endoscopic suturing will be performed in cases of patients randomized to suture fixation.

Group II: Non-suturePlacebo Group1 Intervention

Esophageal stent will be placed in standard of care fashion by the endoscopists using standard gastroscopes. No sutures will be placed to fixate the stent

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Who is running the clinical trial?

West Virginia UniversityLead Sponsor

175 Previous Clinical Trials

56,246 Total Patients Enrolled

Shailendra SinghPrincipal InvestigatorWest Virginia University

Arunkumar KrishnanStudy DirectorWest Virginia University

Frequently Asked Questions

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

How many participants has been accepted into this medical study?

"Confirmed. Through clinicaltrials.gov, it is evident that this experiment has been actively recruiting since July of 2021 and was most recently updated in August 2022. The study aims to enrol 60 research participants at a single site."

Answered by AI

Is this research effort enrolling participants of legal maturity?

"This clinical trial has set the minimum age for enrollment at 18 and the maximum age cap is 99."

Answered by AI

Is this research project actively seeking participants?

"Clinicaltrials.gov shows that this research is currently accepting participants, with the trial initially being published on July 20th 2021 and last amended August 27th 2022."

Answered by AI

Is it feasible for me to participate in this investigation?

"To be enrolled in this medical trial, participants must have dysphagia and esophageal issues along with an age between 18 to 99 years old. The research initiative is aiming to acquire 60 people in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Migration Rates of Sutured vs Non-sutured Esophageal Stent Placement

Shailendra Singh 2021. "Migration Rates of Sutured vs Non-sutured Esophageal Stent Placement". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05082948.