A Multi-center, International Prospective Follow up Study

NCT04579913 | Terminated

• 1 other identifier: MT-03A
• Study Type: observational
• Target: 17
• Locations: 2 countries
• Sites: 5

Brief Summary

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

Conditions

Benign Prostatic Hyperplasia (BPH)

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• iTind Efficacy

  36 months post procedure

• iTind Efficacy

  48 months post procedure

• iTind Efficacy

  60 months post procedure

• iTind Efficacy

  36 months post procedure

• iTind Efficacy

  48 months post procedure

Study Arms (1)

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

Interventions

Review of medical history, administration of questionnaires, uroflowmetry and PVR as measured by ultrasound OTHER

Administration of questionnaires to assess patient LUTS, quality of life, sexual behavior and erectile function, in addition to performing PVR and uroflow tests.

iTind subjects

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Subject signed informed consent form (ICF)
• Subject who had participated in the MT-03 study in the iTind arm
• Subject able to comply with the study protocol.

You may not qualify if:

• Any anatomical or physiological condition that in the opinion of the investigator likely to impede successful completion of the study
• Patients that are known to have had undergone an alternative surgical procedure for BPH during MT-03 study.

Sponsors & Collaborators

• Medi-Tate Ltd.: lead

Study Sites (5)

Clinical Research Center of Florida

Pompano Beach, Florida, 33060, United States

Location

Manhattan Medical research

Manhattan, New York, 10016, United States

Location

Premier Urology Group

New York, New York, 08857, United States

Location

Lenox Hill Hospital

New York, New York, 10075, United States

Location

Toronto

Toronto, Ontario, Canada

Location

Related Links

• Company website

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 8, 2020
• Study Start: December 21, 2020
• Primary Completion: March 12, 2021
• Study Completion: April 22, 2021
• Last Updated: April 29, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (4)