Health TrialsbyHealthPanel

Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction

ConditionErectile Dysfunction Following Radical Prostatectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age30-75
SponsorComphya Inc.

About this trial

The goal of this clinical trial is to assess if a new device is safe to use as a potential treatment for erectile dysfunction following radical prostatectomy.

The main questions it aims to answer are:

* Is the device safe? * Does the device works well? Are the participants satisfied with the device?

Participants will be implanted with the device during the ongoing prostatectomy surgery and will be asked to complete the following tasks during 6 months follow-up:

* Come to the hospital for follow-up visits, * Complete questionnaires, * Activate the device every day, * Measure erection hardness.

Researchers will compare an implanted group (participants having the device) with a control group (participants not having the device) to see if the device works well.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men of ages between 30-75 years with indication for nerve-sparing prostatectomy surgery;

Cancer stage T1c and T2a;

Grade Groups 1 and 2 as well as low volume Grade Group 3 (Gleason score 4 + 3 = 7), as determined by biopsy (2 cores or less GG3) or single index MRI lesion of GG3 disease;

IIEF-15 erectile function domain score equal to or greater than 26;

Disqualifiers

Men with neurological disease, including a history of spinal cord injury or trauma;

IIEF-15 erectile function domain score less than 26;

Failure to demonstrate adequate nocturne erectile function prioi prostatectomy (nocturnal RigiScan measure);

Men with PSA > 20 ng/mL;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Activation of pro-erectile nerves within the pelvic plexus

    Device

    The study device is an active implantable device. The device activates the pro-erectile nerves by delivering electrical pulses. The daily delivery of electrical pulses to the pro-erectile nerves may allow participants to recover natural erectile function.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Implanted groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Occurrence of adverse events

Adverse events will be systematically reported.

Time frame
6 months
2

Occurrence of surgical complications

Surgical complications will be ranked according to the Clavien-Dindo classification

Time frame
6 months
3

Occurrence of device deficiencies

Device deficiencies will be systematically reported and recorded.

Time frame
6 months
4

Pain assessment

Participants will be asked to rate pain on a visual analog scale (from 0 to 10)

Time frame
6 months

Secondary outcomes

1

Device Effectiveness

Device effectiveness will be assessed by asking participants to complete validated questionnaires.

Time frame
6 months
2

Erectile function rehabilitation

Nocturnal penile erections will be assessed with the RigiScan device. Nocturnal erections reflect the extent of rehabilitation of natural erectile function.

Time frame
6 months
3

Duration of Surgical Implantation Procedure

Time (in minutes) from initial implant placement to final suture of the implant.

Time frame
During surgical procedure
4

Ease of Implantation Steps

Surgeon-reported rating of the ease of each implantation step using a standardized ordinal scale.

Time frame
During surgical procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Comphya Inc.

Lead sponsor

Source ClinicalTrials.gov
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