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Prostatic Urethral Lift in Subject With Acute Urinary Retention

NCT03194737 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2021-07-16

Study results available
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Summary

Assess feasibility and safety of the Prostatic Urethra Lift (PUL) procedure in patients with acute urinary retention secondary to benign prostatic hyperplasia (BPH).

Conditions

  • Acute Urinary Retention
  • Benign Prostatic Hyperplasia

Interventions

DEVICE

UroLift System Procedure

Minimally invasive procedure in patients with acute urinary retention secondary to BPH.

Sponsors & Collaborators

  • NeoTract, Inc.

    lead INDUSTRY

Principal Investigators

  • Neil Barber · Frimley Park Hospital

  • Oliver Kayes · St James's University Hosptial

  • Mark Rochester · Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)

  • Toby Page · Freeman Health System

  • Rajesh Kavia · Central Middlesex Hospital

  • Nikesh Thiruchelvam · Cambridge University Hospitals NHS Foundation Trust

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-24
Primary Completion
2019-01-21
Completion
2020-03-03
FDA Device
Yes

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 NCT03194737 on ClinicalTrials.gov