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Device

iTind vs UroLift for Enlarged Prostate (MT-08 Trial)

N/A
Recruiting
Led By Bilal Chughtai, MD
Research Sponsored by Medi-Tate Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males ≥ 50 years of age or older
Diagnosis of lower urinary tract symptoms presumed to be secondary to benign prostatic enlargement causing bladder outlet obstruction for which treatment is recommended
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months
Awards & highlights

MT-08 Trial Summary

This trialwill compare the safety of a new prostate treatment called iTind to the already approved UroLift.

Who is the study for?
Men aged 50 or older with an enlarged prostate (up to 75 cc in size) and symptoms of bladder outlet obstruction can join this trial. They must have a PSA level below 4 mg/dl, or if between 4-10 mg/dl, a negative biopsy within the last six months. Participants need to be able to complete study visits and questionnaires.Check my eligibility
What is being tested?
This study is comparing the safety of two minimally invasive procedures for treating benign prostatic hyperplasia: iTind versus UroLift. Men participating will undergo one of these treatments randomly to see which has fewer complications.See study design
What are the potential side effects?
Possible side effects from iTind and UroLift may include discomfort during urination, blood in urine, urinary tract infection, temporary difficulty with urination, or pelvic pain. Allergic reactions could occur in those sensitive to materials like nickel.

MT-08 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a man aged 50 or older.
Select...
I have symptoms from an enlarged prostate that needs treatment.
Select...
I am willing and able to attend all study visits and complete questionnaires.
Select...
My prostate size is 75 cc or less, confirmed by imaging within the last 6 months.
Select...
My urine flow rate is between 5 and 12 mL/sec.
Select...
I have symptoms from an enlarged prostate that needs treatment.

MT-08 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 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
Primary Safety
Secondary outcome measures
Secondary Efficacy

MT-08 Trial Design

2Treatment groups
Experimental Treatment
Group I: iTind armExperimental Treatment1 Intervention
The iTind is a minimally invasive temporary implant
Group II: UroLiftExperimental Treatment1 Intervention
The UroLift is a minimally invasive permanent implant
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
UroLift
2018
N/A
~20

Find a Location

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
20 Previous Clinical Trials
1,965 Total Patients Enrolled
Bilal Chughtai, MDPrincipal InvestigatorNorthwell Health
5 Previous Clinical Trials
177 Total Patients Enrolled

Media Library

iTind (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04757116 — N/A
Enlarged Prostate Research Study Groups: iTind arm, UroLift
Enlarged Prostate Clinical Trial 2023: iTind Highlights & Side Effects. Trial Name: NCT04757116 — N/A
iTind (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04757116 — N/A

Frequently Asked Questions

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

Does the eligibility criteria of this investigation include persons aged 45 and above?

"The entry requirements for this clinical trial stipulate that the minimum age of enrollees must be at least 50, while the upper limit is set to 80 years old."

Answered by AI

What is the current enrollment for this research project?

"Medi-Tate Ltd. is looking to enroll 250 participants that meet the study's criteria across two different sites, The University of Toledo in Ohio and University of Kansas Medical Research Institute, Inc. in Kansas City."

Answered by AI

Does my present condition meet the criteria to join this medical investigation?

"Participants with benign prostatic hyperplasia (bph) between the ages of 50 and 80 are welcome to apply for this study. The recruitment goal is 250 patients in total."

Answered by AI

Is enrollment currently available for this trial?

"Affirmative. Clinicaltrials.gov data affirms that this clinical trial, which was initially publicized on September 26th 2022, is currently recruiting participants. A total of 250 individuals need to be enrolled from 11 different medical centres."

Answered by AI

How many health care facilities are facilitating this investigation?

"The University of Toledo in Toledo, Ohio; the University of Kansas Medical Research Institute, Inc. in Kansas City, Kansas; Golden State Urology in Sacramento California are among 11 other sites offering this medical trial."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
What portion of applicants met pre-screening criteria?
Did not meet criteria
~83 spots leftby Dec 2024