CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 110 enrolled
Drug / intervention
RestoreX PTT - randomized and open label +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03389854
NCT03389854N/ACompleted
CompareCT.gov

Efficacy of Penile Traction Therapy Using a Novel Device: A Controlled, Single-blinded, Randomized Trial

Mayo Clinic·interventional·Posted Jan 4, 2018·Updated Aug 12, 2020

In Brief

A clinical study evaluating RestoreX PTT - randomized and open label and RestoreX PTT - open label phase only for Penile Diseases. Completed, enrolled 110 participants across 1 site.

Detailed Summary

This clinical trial is designed to assess the safety, dosing, and preliminary efficacy of a novel penile traction device on correcting deformities relating to Peyronie's disease, a condition which results in penile curvature and length loss. The trial is designed as a randomized, placebo-controlled study with men randomized to receiving no therapy or penile traction therapy 30 minutes once, twice, or three times daily. The study will occur over a 3 month period, after which an open label phase for 3 months will be conducted. Final assessments for adverse effects will also be assessed at 9 months.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPenile Diseases
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJan 4, 2018
Enrollment StartOct 2, 2017
Primary CompletionJun 4, 2019
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 8.5 years ago

Interventions

RestoreX PTT - randomized and open labeldevice

Penile traction therapy in the straight and bent positions

RestoreX PTT - open label phase onlydevice

Penile traction therapy in the straight and bent positions