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Procedure

Rezum for Enlarged Prostate

N/A

Waitlist Available

Led By Bilal Chughtai, MD

Research Sponsored by Weill Medical College of Cornell 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 baseline, 36 months

Awards & highlights

Study Summary

This trial is testing whether a new Rezum procedure that doesn't require a post-operative catheter is effective. If it is, they will test it at 5 more sites.

Eligible Conditions

Enlarged Prostate

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 36 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

Feasibility of Catheterless Rezum as measured by changes in the International Prostate Symptom Score (IPSS).

Feasibility of Catheterless Rezum as measured by changes in the maximum urinary flow rate (Qmax).

Secondary outcome measures

Changes in urinary symptoms as measured by changes in IPSS.

Changes in urinary symptoms as measured by changes in Qmax at 36 months

Trial Design

1Treatment groups

Experimental Treatment

Group I: Catheterless groupExperimental Treatment1 Intervention

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Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor

1,054 Previous Clinical Trials

1,316,508 Total Patients Enrolled

Boston Scientific CorporationIndustry Sponsor

718 Previous Clinical Trials

932,928 Total Patients Enrolled

Bilal Chughtai, MDPrincipal InvestigatorWeill Medical College of Cornell University

5 Previous Clinical Trials

407 Total Patients Enrolled

Media Library

Rezum (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04997369 — N/A

Enlarged Prostate Research Study Groups: Catheterless group

Enlarged Prostate Clinical Trial 2023: Rezum Highlights & Side Effects. Trial Name: NCT04997369 — N/A

Rezum (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04997369 — N/A

Frequently Asked Questions

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

Are there any vacancies in the clinical trial for new participants?

"According to clinicaltrials.gov, this research is currently enrolling participants. The trial was made available on October 13th 2021 and its last update came November 15th 2022."

Answered by AI

May I be considered as a potential participant in this clinical investigation?

"Candidates for this medical study must be between 40 and 80 years of age, suffering from benign prostatic hyperplasia (BPH). In total, the trial is looking to enroll 20 participants."

Answered by AI

Is this investigation open to participants aged 65 and above?

"This study is accepting patients from the age of 40 up to 80 years. There are 28 research initiatives for those who fall below 18 and 105 for individuals over 65."

Answered by AI

What is the exact number of participants enrolled in this clinical research endeavor?

"Affirmative. The information hosted on clinicaltrials.gov states this medical research is currently recruiting participants, having been initially posted on October 13th 2021 and most recently updated 15th November 2022. A total of 20 people must be sourced from a single site for participation in the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Catheterless Water Vapor Therapy for the Treatment of BPH

2021. "Catheterless Water Vapor Therapy for the Treatment of BPH". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04997369.