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The study will include an implantation of the iTind device and 4 follow up visits up to 12 months after the implantation.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medi-Tate iTind | Experimental | TIND System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TIND System | Device | An implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary peak flow | Increase of maximal urinary peak flow | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claude Schulman, MD | Edith cavell clinic, Belgium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edith Cavell | Brussels | Belgium | ||||
| Gent Hospital University |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 27, 2023 | |
| Reset | Feb 15, 2024 | |
| Release | Feb 20, 2024 | |
| Reset | Aug 1, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 27, 2023 | Feb 15, 2024 | |||
| Feb 20, 2024 |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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iTind
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| Ghent |
| Belgium |
| San Orbessano | Turin | Italy |
| La Paz Hospital | Madrid | Spain |
| Kantonsspital Frauenfeld | Frauenfeld | Switzerland |
| Lausanne University Hospital | Lausanne | Switzerland |
| Frimley Health NHS | London | United Kingdom |
| University College Hospital | London | United Kingdom |
| Aug 1, 2024 |
| D052801 |
| Male Urogenital Diseases |