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Study to Assess the Efficacy of Medi-Tate iTind Device

Primary Purpose

Benign Prostatic Hyperplasia (BPH)

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
TIND System
Sponsored by
Medi-Tate Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia (BPH) focused on measuring BPH

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • Any serious medical condition likely to impede successful completion of the study.

Sites / Locations

  • Edith Cavell
  • Gent Hospital University
  • San Orbessano
  • La Paz Hospital
  • Kantonsspital Frauenfeld
  • Lausanne University Hospital
  • Frimley Health NHS
  • University College Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Medi-Tate iTind

Arm Description

TIND System

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Urinary peak flow
Increase of maximal urinary peak flow

Full Information

First Posted
May 20, 2014
Last Updated
April 3, 2022
Sponsor
Medi-Tate Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02145208
Brief Title
Study to Assess the Efficacy of Medi-Tate iTind Device
Official Title
One-arm, Multi-center, International Prospective Study to Assess the Efficacy of Medi-Tate Temporary Implantable Nitinol Device (iTindTM) in Subjects With Benign Prostatic Hypertrophy (BPH).
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
November 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medi-Tate Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study will include an implantation of the iTind device and 4 follow up visits up to 12 months after the implantation.
Detailed Description
After screening , eligible patients will undergo an an implantation procedure (operative), using the iTind device. Implantation will be performed according to the Instructions For Use. Between the 5th - 7th days, the iTind will be retrieved through a rigid cystoscope sheath, under direct vision. Before retrieval the subject will be asked for subjective discomfort evaluation and level of urgency in the past days after device insertion, about any AE and then the device will be retrieved. The next visits will be at 4 weeks (post device retrieval), 3 months, 6 months, and 12 months post implantation with an optional extension of follow up period (up to 36 months). In the visits the following will be assessed: Uroflow and residual urine volume tests, AE recording, IPSS, and Questions on sex performing capability and ejaculation filled out by the subjects, in the local languages.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia (BPH)
Keywords
BPH

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
iTind
Masking
None (Open Label)
Allocation
N/A
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medi-Tate iTind
Arm Type
Experimental
Arm Description
TIND System
Intervention Type
Device
Intervention Name(s)
TIND System
Intervention Description
An implant
Primary Outcome Measure Information:
Title
IPSS
Description
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.
Time Frame
6 months.
Title
SAE
Description
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.
Time Frame
5-7 days
Secondary Outcome Measure Information:
Title
Urinary peak flow
Description
Increase of maximal urinary peak flow
Time Frame
12 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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. Any serious medical condition likely to impede successful completion of the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claude Schulman, MD
Organizational Affiliation
Edith cavell clinic, Belgium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Edith Cavell
City
Brussels
Country
Belgium
Facility Name
Gent Hospital University
City
Gent
Country
Belgium
Facility Name
San Orbessano
City
Turin
Country
Italy
Facility Name
La Paz Hospital
City
Madrid
Country
Spain
Facility Name
Kantonsspital Frauenfeld
City
Frauenfeld
Country
Switzerland
Facility Name
Lausanne University Hospital
City
Lausanne
Country
Switzerland
Facility Name
Frimley Health NHS
City
London
Country
United Kingdom
Facility Name
University College Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study to Assess the Efficacy of Medi-Tate iTind Device

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