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DualStim Therapy With or Without Umbilical Cord Derived Wharton's Jelly for Erectile Dysfunction

NCT04424394 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-07-21

No results posted yet for this study

Summary

The purpose of this study is to determine the immediate and short-term efficacy of the methodological application of DualStim Therapy - Focused Extracorporeal Shock Wave Therapy (fESWT) and Radial Extracorporeal Shock Wave Therapy (rESWT), with and without intracavernosal administration of formulated umbilical cord derived Wharton's Jelly to improve and/or restore erectile function in patients with erectile dysfunction (ED).

Conditions

Interventions

DEVICE

DualStim Therapy

6 DualStim Therapies over a period of 7 weeks.

BIOLOGICAL

Umbilical cord-derived Wharton's Jelly

2 intracavernosal injections over a period of 7 weeks.

OTHER

Saline

2 intracavernosal injections over a period of 7 weeks.

Sponsors & Collaborators

  • BioIntegrate

    lead INDUSTRY

Principal Investigators

  • Richard Gaines, MD · LifeGAINES Medical and Aesthetics Center

  • Ashim Gupta, PhD, MBA · BioIntegrate

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2024-12-31
Completion
2024-12-31
FDA Device
Yes

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Entities

Diseases

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 NCT04424394 on ClinicalTrials.gov