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Penile Length Maintenance Post-Prostatectomy

NCT03500419 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2021-10-20

Study results available
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Summary

The objective of the current study is to evaluate the efficacy of a novel, class I (ie. lowest risk, clinical studies not required) medical penile traction device in preventing loss of penile length in men undergoing robotic-assisted prostatectomy.

Conditions

Interventions

DEVICE

RestoreX

PTT - Penile traction therapy in the straight position.

OTHER

No treatment

Control group. No treatment will be given for the 6 months post-prostatectomy

Sponsors & Collaborators

Principal Investigators

  • Matthew Ziegelmann, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-23
Primary Completion
2020-12-28
Completion
2020-12-28
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
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 NCT03500419 on ClinicalTrials.gov