Study to Assess the Efficacy of Medi-Tate iTind Device

NCT02145208 | Completed

• 1 other identifier: MT-02
• Study Type: interventional
• Target: 81
• Locations: 5 countries
• Sites: 8

Brief Summary

The study will include an implantation of the iTind device and 4 follow up visits up to 12 months after the implantation.

Conditions

Benign Prostatic Hyperplasia (BPH)

Keywords

BPH

Outcome Measures

Primary Outcomes (2)

• IPSS

  Change of IPSS score by at least 3 points, in at least 75 % of the subjects, at 6 months follow-up. IPSS - The International Prostate Symptom Score. Scale: minimum 0 (zero), maximum 35. Lower values are better.

  6 months.

• SAE

  The incidence of unexpected serious adverse events related to Meditate iTind and/or implantation/retrieval procedures, as determined by the investigator and the study medical monitor.

  5-7 days

Secondary Outcomes (1)

• Urinary peak flow

  12 months

Study Arms (1)

Medi-Tate iTind

EXPERIMENTAL

TIND System

Device: TIND System

Interventions

TIND System DEVICE

An implant

Medi-Tate iTind

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject signed informed consent prior to the performance of any study procedures.
• Male with symptomatic BPH. IPSS symptom severity score above 10. Peak urinary flow of below 12 ml/sec
• Prostate volume below 75 ml
• Blood CBC and biochemistry up to two weeks before screening demonstrating: Normal values of the PT, PTT and INR tests (anticoagulants should be stopped according to GCP)
• Subject that able to complete the study protocol.
• Normal Urinalysis and urine culture

You may not qualify if:

• cardiac arrhythmias, cardiac disease including congestive heart failure, uncontrolled diabetes mellitus, significant respiratory disease, or known immunosuppression;
• neurogenic bladder and/or sphincter abnormalities due to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes, etc.;
• a post void residual (PVR) volume above 250 ml measured by ultrasound or acute urinary retention
• compromised renal function (i.e., serum creatinine level above 1.8 mg/dl, or upper tract disease);
• confirmed or suspected bladder cancer;
• recent (within 3 months) cystolithiasis or hematuria;
• urethral strictures, bladder neck contracture, Urinary bladder stones
• or other potentially confounding bladder pathology;
• an active urinary tract infection.
• Enrolled in another treatment trial for any disease within the past 30 days.
• previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease if the therapy may potentially cause injury to sites of previous rectal surgery, e.g., if a transrectal probe is used;
• previous pelvic irradiation or radical pelvic surgery;
• previous prostate surgery, balloon dilatation, stent implantation, laser prostatectomy, hyperthermia, or any other invasive treatment to the prostate
• Cancer that is not considered cured, except basal cell or squamous cell carcinoma of the skin (cured defined as no evidence of cancer within the past 5 years).
• Subject has an interest in future fertility and is not willing to undergo fertility treatments whatsoever.

Sponsors & Collaborators

• Medi-Tate Ltd.: lead

Study Sites (8)

Edith Cavell

Brussels, Belgium

Location

Gent Hospital University

Ghent, Belgium

Location

San Orbessano

Turin, Italy

Location

La Paz Hospital

Madrid, Spain

Location

Kantonsspital Frauenfeld

Frauenfeld, Switzerland

Location

Lausanne University Hospital

Lausanne, Switzerland

Location

Frimley Health NHS

London, United Kingdom

Location

University College Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

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

Study Officials

• Claude Schulman, MD

  Edith cavell clinic, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: iTind

Study Record Dates

• First Submitted: May 20, 2014
• First Posted: May 22, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: November 1, 2021
• Last Updated: April 11, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2); ES (1); IT (1); BE (2); GB (2)