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Efficacy of Penile Traction Therapy Using a Novel Device

NCT03389854 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2020-08-12

Study results available
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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.

Conditions

  • Penile Diseases

Interventions

DEVICE

RestoreX PTT - randomized and open label

Penile traction therapy in the straight and bent positions

DEVICE

RestoreX PTT - open label phase only

Penile traction therapy in the straight and bent positions

Sponsors & Collaborators

Principal Investigators

  • Landon Trost, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-02
Primary Completion
2019-06-04
Completion
2019-06-04
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT03389854 on ClinicalTrials.gov