A Multi-center, International Prospective Follow up Study

• Sponsor: Medi-Tate Ltd. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT04579913
• Collaborator: (none)
• Enrollment: 17
• Locations: 5
• Actual Duration (Months): 4
• Patients Per Site: 3.4
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Benign Prostatic Hyperplasia (BPH)	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 Design

• Study Type: Observational
• Actual Enrollment: 17 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Dec 21, 2020
• Actual Primary Completion Date: Mar 12, 2021
• Actual Study Completion Date: Apr 22, 2021

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. iTind Durability [36 months post procedure]

   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.

2. iTind Durability [48 months post procedure]

   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.

3. iTind Durability [60 months post procedure]

   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.

Secondary Outcome Measures

1. iTind Efficacy [36 months post procedure]

   Change from baseline in IPSS

2. iTind Efficacy [48 months post procedure]

   Change from baseline in IPSS

3. iTind Efficacy [60 months post procedure]

   Change from baseline in IPSS

4. iTind Efficacy [36 months post procedure]

   Change from baseline in Qmax

5. iTind Efficacy [48 months post procedure]

   Change from baseline in Qmax

6. iTind Efficacy [60 months post procedure]

   Change from baseline in Qmax

7. iTind Safety [36 months post procedure]

   Safety will be assessed by the rate of complications attributed to iTind since the last recorded follow up from MT-03 study

8. iTind Safety [48 months post procedure]

   Safety will be assessed by the rate of complications attributed to iTind since the last recorded follow up from MT-03 study

9. iTind Safety [60 months post procedure]

   Safety will be assessed by the rate of complications attributed to iTind since the last recorded follow up from MT-03 study

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Research Center of Florida	Pompano Beach	Florida	United States	33060
2	Manhattan Medical research	Manhattan	New York	United States	10016
3	Premier Urology Group	New York	New York	United States	08857
4	Lenox Hill Hospital	New York	New York	United States	10075
5	Toronto	Toronto	Ontario	Canada

Sponsors and Collaborators

• Medi-Tate Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Company website

Publications

None provided.

• Responsible Party: Medi-Tate Ltd.
• ClinicalTrials.gov Identifier: NCT04579913
• Other Study ID Numbers: MT-03A
• First Posted: Oct 8, 2020
• Last Update Posted: Apr 29, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prostatic Hyperplasia; Hyperplasia

Study Results

No Results Posted as of Apr 29, 2021