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Study to Assess the Efficacy, Safety and Tolerability of (iTind)

NCT03239951 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2020-07-22

No results posted yet for this study

Summary

Subjects with AUR secondary to BPO that comply with Inclusion/Exclusion Criteria.

A total of 50 eligible subjects will be recruited into the study to receive treatment with iTind system.

Study duration will be 12 months post implantation, with follow-up extension of up to 3 years. Extension of follow up period will not require an additional ICF.

Conditions

  • BPH

Interventions

DEVICE

iTind

temporary implant

Sponsors & Collaborators

  • Medi-Tate Ltd.

    lead INDUSTRY

Principal Investigators

  • Gordon Muir, MD · King's College Hospital NHS Trust

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
90 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-27
Primary Completion
2020-01-20
Completion
2020-03-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03239951 on ClinicalTrials.gov