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Study to Assess the Efficacy of the iTind in Subjects With Symptomatic BPH (MT-06)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03395522
Recruitment Status : Active, not recruiting
First Posted : January 10, 2018
Last Update Posted : June 1, 2023
Sponsor:
Information provided by (Responsible Party):
Medi-Tate Ltd.

Study Description
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Brief Summary:

A total of up to 200 Symptomatic BPH subjects subjects will be enrolled into the study.

Study duration will be 12 months post implantation with a follow-up visits at Year 2 and Year 3.


Condition or disease Intervention/treatment Phase
BPH Device: iTind Not Applicable

Detailed Description:

Primary Study Objective:

The study's primary objective is to assess the efficacy of the Medi-Tate iTind in subjects with symptomatic BPH by reduction of IPSS) (International Prostate Symptoms Score) score.

Secondary Study Objectives:

  • To further evaluate the efficacy of Medi-Tate iTind as determined by increase of maximal urinary peak flow, satisfaction from the device and procedures, sex performance capabilities and ejaculation.
  • Safety will be assessed by the rate of complications attributed to the Medi-Tate iTind and its implantation/retrieval procedures.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 149 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: device group only
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: One-arm, Multi-center, International Prospective Study to Assess the Efficacy of Medi-tate Temporary Implantable Nitinol Device (iTind) in Subjects With Symptomatic Benign Prostatic Hyperplasia (BPH)
Actual Study Start Date : February 18, 2018
Estimated Primary Completion Date : June 18, 2023
Estimated Study Completion Date : April 25, 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: Device
ITind device implant
 Device: iTind
device implanted for 5-7 days


Outcome Measures
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Primary Outcome Measures :
  1. IPSS (International Prostate Symptoms Score) Responders Rate [ Time Frame: at Month 6 Visit ]
    the Proportion (%) of Total IPSS Responders (3 points) Rate


Secondary Outcome Measures :
  1. Total IPSS (International Prostate Symptoms Score) Score at [ Time Frame: 6 months ]
    Change from Baseline to Month 6 in Total IPSS Score

  2. Total IPSS(International Prostate Symptoms Score) Urinary Symptoms Score [ Time Frame: 6 months ]
    Change from Baseline to Month 6 in Total IPSS Urinary Symptoms Score

  3. Total SHIM (Sexual Health Inventory for Men ) Score [ Time Frame: 6 months ]
    Change from Baseline to Month 6 in Total SHIM Score

  4. Total ISI (Incontinence Severity Index ) Score [ Time Frame: 6 months ]
    Change from Baseline to Month 6 in Total ISI Score

  5. Total EJ-MSHQ ( Ejaculation- Male Sexual Health questionnaire) Score [ Time Frame: 6 months ]
    Change from Baseline to Month 6 in Total EJ-MSHQ Score

  6. Total Flow [ Time Frame: 6 months ]
    Change from Baseline to Month 6 in Total Flow

  7. Total residual urine [ Time Frame: 6 months ]
    Change from Baseline to Month 6 in Total residual urine

  8. Total Satisfaction Rate [ Time Frame: 6 months ]
    Change from Baseline to Month 6 in Total Satisfaction Rate

  9. IPSS QoL (Quality Of Life) score [ Time Frame: 6 months ]
    Change from Baseline to Month 6 in IPSS QoL score

  10. Recovery Success Rate [ Time Frame: 1 month ]
    Quality of Recovery Success Rate


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male with symptomatic BPH
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subject signed informed consent prior to the performance of any study procedures.

  • Male with symptomatic BPH: IPSS symptom severity score ≥ 10
  • Peak urinary flow of < 12 ml/sec at flowmetry with minimum voided volume of at least 120 cc.
  • Prostate volume 25 ml to 80 ml (as assessed by TRUS)
  • Subject that is able to complete the study protocol
  • Normal Urinalysis and urine culture.

Exclusion Criteria:

  • Previous prostate surgery
  • Prostate cancer
  • Urethral stricture
  • Bladder stones
  • An active urinary tract infection.
  • Obstructing median lobe demonstrated by IPP grade 3 (>1 cm) as assessed by TRUS.
  • Neurological conditions potentially affecting voiding function.
  • A post void residual (PVR) volume > 250 ml measured by ultrasound
  • Previous diagnosis or treatment for Over Active Bladder
  • Acute Urinary Retention
  • Any anatomical or physiological condition that in the opinion of the investigator likely to impede successful completion of the study

Intra-Operation Exclusion:

• Obstructing median lobe or any other anatomical or physiological pathology that can interfere the device implantation as assessed by cystoscopy.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03395522


Locations
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Australia
Sydney Adventist Hospital Clinical School of the University of Sydney
Sydney, Australia
France
Hospital Center University De Bordeaux
Bordeaux, France
Hôpital Cochin
Paris, France
Hôpital Privé des Côtes d'Armor
Plérin, France
Germany
University Hospital Frankfurt
Frankfurt, Germany
Medical center - University of Freiburg
Freiburg, Germany
Italy
AOU di Catanzaro
Catanzaro, Italy
Azienda Ospedaliera Universitaria San Martino
Genova, Italy
San'Andrea Hospital
Rome, Italy
San Orbessano
Turin, Italy
Spain
Clínica CEMTRO Ventisquero la Condesa
Madrid, Spain, 42 28035
Switzerland
Cantonal Hospital St. Gallen
Saint Gallen, Switzerland
Sponsors and Collaborators
Medi-Tate Ltd.
Investigators
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Principal Investigator: Francesco Porpiglia, MD San Orbessano
More Information
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Responsible Party: Medi-Tate Ltd.
ClinicalTrials.gov Identifier: NCT03395522    
Other Study ID Numbers: MT-06
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: June 1, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No