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Trial record 2 of 2 for:    itind meditate

Study to Assess the Efficacy of Medi-Tate iTind Device

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: NCT02145208
Recruitment Status : Active, not recruiting
First Posted : May 22, 2014
Last Update Posted : March 12, 2020
Sponsor:
Information provided by (Responsible Party):
Medi-Tate Ltd.

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

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia (BPH) Device: TIND System Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: iTind
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 (iTindTM) in Subjects With Benign Prostatic Hypertrophy (BPH).
Actual Study Start Date : October 2014
Actual Primary Completion Date : December 2017
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Medi-Tate iTind
TIND System
Device: TIND System
An implant




Primary Outcome Measures :
  1. Reduction of IPSS score by at least 3 points, in at least 75 % of the subjects, at 6 months follow-up. [ Time Frame: 6 months ]
  2. 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 Measures :
  1. Increase of maximal urinary peak flow [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
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 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.

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): NCT02145208


Locations
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Belgium
Edith Cavell
Brussels, Belgium
Gent Hospital University
Gent, Belgium
Italy
San Orbessano
Turin, Italy
Spain
La Paz Hospital
Madrid, Spain
Switzerland
Kantonsspital Frauenfeld
Frauenfeld, Switzerland
Lausanne University Hospital
Lausanne, Switzerland
United Kingdom
Frimley Health NHS
London, United Kingdom
University College Hospital
London, United Kingdom
Sponsors and Collaborators
Medi-Tate Ltd.
Investigators
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Principal Investigator: Claude Schulman, MD Edith cavell clinic, Belgium
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Responsible Party: Medi-Tate Ltd.
ClinicalTrials.gov Identifier: NCT02145208    
Other Study ID Numbers: MT-02
First Posted: May 22, 2014    Key Record Dates
Last Update Posted: March 12, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Medi-Tate Ltd.:
BPH
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases