iTind arm for Enlarged Prostate

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Enlarged ProstateUroLift - Procedure
Eligibility
50 - 80
Male
What conditions do you have?
Select

Study Summary

The study objective is to demonstrate the safety of the iTind as compared to the UroLift.

Eligible Conditions
  • Enlarged Prostate

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 48 months

48 Months
Primary Safety
48 months
Secondary Efficacy

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

iTind arm
1 of 3
UroLift
1 of 3
TURP arm
1 of 3

Experimental Treatment

250 Total Participants · 3 Treatment Groups

Primary Treatment: iTind arm · No Placebo Group · N/A

iTind arm
Device
Experimental Group · 1 Intervention: iTind · Intervention Types: Device
UroLift
Procedure
Experimental Group · 1 Intervention: UroLift · Intervention Types: Procedure
TURP arm
Procedure
Experimental Group · 1 Intervention: TURP · Intervention Types: Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
UroLift
2018
N/A
~20
TURP
2012
Completed Phase 4
~290

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 48 months

Who is running the clinical trial?

Medi-Tate Ltd.Lead Sponsor
7 Previous Clinical Trials
470 Total Patients Enrolled
Olympus Corporation of the AmericasLead Sponsor
8 Previous Clinical Trials
1,051 Total Patients Enrolled
Bilal Chughtai, MDPrincipal InvestigatorNew York Presbyterian Hospital-Weill Cornell
5 Previous Clinical Trials
177 Total Patients Enrolled
Neil Barber, MDPrincipal InvestigatorFrimley Park Hospital

Eligibility Criteria

Age 50 - 80 · Male Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The results may be accepted up to 6 months prior to the Screening/Baseline Visit
You are willing and able to complete all study visits including questionnaires at baseline and at follow-up visits.