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NCT04579913 Clinical Trial

A Multi-center, International Prospective Follow up Study

Benign Prostatic Hyperplasia (BPH) Clinical Trial

Official title:
A Multi-center, International Prospective Follow up Study to Assess the Safety and Efficacy of the iTind Procedure After Three to Five Years of Follow Up

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04579913
Other study ID # MT-03A
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date December 21, 2020
Est. completion date April 22, 2021

Study information
Verified date April 2021
Source Medi-Tate Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study objective is to assess the safety and efficacy of iTind three to five years following treatment.

Description:

This study will recruit patients who participated in the MT-03 study in the iTind arm to assess the safety and efficacy of the iTind procedure at three to five years following treatment as demonstrated by reduction of symptoms measured by IPSS and QoL and improvement of functional parameters as measured by peak urinary flow and PVR. Sexual and erectile function will also be assessed alongside the incidence of any related late occurring adverse events.

Recruitment information / eligibility
Status Terminated
Enrollment 17
Est. completion date April 22, 2021
Est. primary completion date March 12, 2021
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility Inclusion Criteria: 1. Subject signed informed consent form (ICF) 2. Subject who had participated in the MT-03 study in the iTind arm 3. Subject able to comply with the study protocol. Exclusion Criteria: 1. Any anatomical or physiological condition that in the opinion of the investigator likely to impede successful completion of the study 2. Patients that are known to have had undergone an alternative surgical procedure for BPH during MT-03 study.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Review of medical history, administration of questionnaires, uroflowmetry and PVR as measured by ultrasound
Administration of questionnaires to assess patient LUTS, quality of life, sexual behavior and erectile function, in addition to performing PVR and uroflow tests.

Locations
Country Name City State
Canada Toronto Toronto Ontario
United States Manhattan Medical research Manhattan New York
United States Lenox Hill Hospital New York New York
United States Premier Urology Group New York New York
United States Clinical Research Center of Florida Pompano Beach Florida

Sponsors (1)
Lead Sponsor Collaborator
Medi-Tate Ltd.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary iTind Durability The primary endpoint of the study is time to first alternative surgical BPH intervention, defined as the time (in months) from the iTind procedure to intervention. 36 months post procedure
Primary iTind Durability The primary endpoint of the study is time to first alternative surgical BPH intervention, defined as the time (in months) from the iTind procedure to intervention. 48 months post procedure
Primary iTind Durability The primary endpoint of the study is time to first alternative surgical BPH intervention, defined as the time (in months) from the iTind procedure to intervention. 60 months post procedure
Secondary iTind Efficacy Change from baseline in IPSS 36 months post procedure
Secondary iTind Efficacy Change from baseline in IPSS 48 months post procedure
Secondary iTind Efficacy Change from baseline in IPSS 60 months post procedure
Secondary iTind Efficacy Change from baseline in Qmax 36 months post procedure
Secondary iTind Efficacy Change from baseline in Qmax 48 months post procedure
Secondary iTind Efficacy Change from baseline in Qmax 60 months post procedure
Secondary iTind Safety Safety will be assessed by the rate of complications attributed to iTind since the last recorded follow up from MT-03 study 36 months post procedure
Secondary iTind Safety Safety will be assessed by the rate of complications attributed to iTind since the last recorded follow up from MT-03 study 48 months post procedure
Secondary iTind Safety Safety will be assessed by the rate of complications attributed to iTind since the last recorded follow up from MT-03 study 60 months post procedure
See also
  Status Clinical Trial Phase
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Recruiting NCT04757116 - Post-Market Study to Assess iTind Safety in Comparison to UroLift N/A
Completed NCT03460873 - Prognostic Factor in the Patients With Benign Prostatic Hyperplasia Who Undergo Holmium Laser Enucleation of the Prostate
Completed NCT01218243 - An Efficacy Trial of Electroacupuncture at Points of Bilateral BL33 for Mild and Moderate Benign Prostatic Hyperplasia Phase 2
Completed NCT01566292 - Intraprostatic Botulinum Toxin Type "A" Injection in Patients With Benign Prostatic Hyperplasia and Unsatisfactory Response to Medical Therapy Phase 2/Phase 3
Active, not recruiting NCT00407953 - PROLIEVE® Post-Marketing Study TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH) Phase 4
Completed NCT03191734 - French Aquablation Clinical Investigation Using Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue N/A
Recruiting NCT04838769 - REZŪM vs. Dual Drug Therapy for Symptomatic Benign Prostatic Hyperplasia in Sexually Active Men N/A
Completed NCT03856242 - Benign Prostatic Hyperplasia and Ischemic Heart DIsease Phase 4
Completed NCT04032067 - Evaluate the Efficacy and Safety of GV1001 in Patients With Benign Prostatic Hyperplasia (BPH) Phase 3
Completed NCT02505919 - Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue (WATER) N/A
Completed NCT02855892 - A Phase II Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Patients With BPH Phase 2
Completed NCT02145208 - Study to Assess the Efficacy of Medi-Tate iTind Device N/A
Completed NCT00970632 - A Study of Tadalafil in Men With Benign Prostatic Hyperplasia Phase 3
Recruiting NCT02592473 - Prostate Artery Embolization (PAE) for Treatment of Benign Prostatic Hyperplasia N/A
Completed NCT00945490 - Clinical Evaluation of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) NX02-0018 Phase 3
Completed NCT00759135 - Phase 2 Study of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) (Enlarged Prostate) Phase 2
Completed NCT00224107 - A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo Phase 3
Recruiting NCT04648176 - Application of MOSES Technology in BPH N/A
Terminated NCT00651807 - A Trial to Investigate the Effectiveness and Safety of Org 3236 (Etonogestrel) Tablets in Men With Urinary Complaints Suggestive of a Benign Enlargement of the Prostate (304001)(P05806) Phase 2

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