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
|Condition or disease||Intervention/treatment||Phase|
|Benign Prostatic Hyperplasia (BPH)||Device: TIND System||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||81 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||iTind|
|Masking:||None (Open Label)|
|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|
Experimental: Medi-Tate iTind
Device: TIND System
- 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 ]
- 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 ]
- Increase of maximal urinary peak flow [ Time Frame: 12 months ]
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
|Gent Hospital University|
|La Paz Hospital|
|Lausanne University Hospital|
|Frimley Health NHS|
|London, United Kingdom|
|University College Hospital|
|London, United Kingdom|
|Principal Investigator:||Claude Schulman, MD||Edith cavell clinic, Belgium|