A Multi-center, International Prospective Follow up Study

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

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

Study Overview

• Status: Terminated
• Conditions: Benign Prostatic Hyperplasia (BPH)
• Intervention / Treatment: Other: Review of medical history, administration of questionnaires, uroflowmetry and PVR as measured by ultrasound

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • Toronto
• United States
  • Florida
    • Pompano Beach, Florida, United States, 33060
      • Clinical Research Center of Florida
  • New York
    • Manhattan, New York, United States, 10016
      • Manhattan Medical Research
    • New York, New York, United States, 10075
      • Lenox Hill Hospital
    • New York, New York, United States, 08857
      • Premier Urology Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Any patient who participated in the MT-03 study in the iTind arm who had not undergone an alternative procedure for BPH during the first 12 month follow-up period and who is willing to participate in the current follow up study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
iTind subjects; Patient who participated previously in the MT-03 study in the iTind arm	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
iTind Efficacy	Change from baseline in IPSS	36 months post procedure
iTind Efficacy	Change from baseline in IPSS	48 months post procedure
iTind Efficacy	Change from baseline in IPSS	60 months post procedure
iTind Efficacy	Change from baseline in Qmax	36 months post procedure
iTind Efficacy	Change from baseline in Qmax	48 months post procedure
iTind Efficacy	Change from baseline in Qmax	60 months post procedure
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
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
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

Collaborators and Investigators

• Sponsor: Medi-Tate Ltd.

Publications and helpful links

Helpful Links

• Company website

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 21, 2020
• Primary Completion (ACTUAL): March 12, 2021
• Study Completion (ACTUAL): April 22, 2021

Study Registration Dates

• First Submitted: September 29, 2020
• First Submitted That Met QC Criteria: October 4, 2020
• First Posted (ACTUAL): October 8, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 29, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: MT-03A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No