Trials / Terminated
TerminatedNCT04579913
A Multi-center, International Prospective Follow up Study
A Multi-center, International Prospective Follow up Study to Assess the Safety and Efficacy of the iTind Procedure After Three to Five Years of Follow Up
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 17 (actual)
- Sponsor
- Medi-Tate Ltd. · Industry
- Sex
- Male
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The study objective is to assess the safety and efficacy of iTind three to five years following treatment.
Detailed description
This study will recruit patients who participated in the MT-03 study in the iTind arm to assess the safety and efficacy of the iTind procedure at three to five years following treatment as demonstrated by reduction of symptoms measured by IPSS and QoL and improvement of functional parameters as measured by peak urinary flow and PVR. Sexual and erectile function will also be assessed alongside the incidence of any related late occurring adverse events.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Review of medical history, administration of questionnaires, uroflowmetry and PVR as measured by ultrasound | Administration of questionnaires to assess patient LUTS, quality of life, sexual behavior and erectile function, in addition to performing PVR and uroflow tests. |
Timeline
- Start date
- 2020-12-21
- Primary completion
- 2021-03-12
- Completion
- 2021-04-22
- First posted
- 2020-10-08
- Last updated
- 2021-04-29
Locations
5 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT04579913. Inclusion in this directory is not an endorsement.