FirmTech User Research Trial

Last updated: February 4, 2025
Sponsor: Reproductive Medicine Associates of New Jersey
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

FirmTech Tech Ring

Giddy Penile Constriction Ring

Clinical Study ID

NCT05853822
Firmtech_RMANJ_01
  • Ages 18-70
  • Male

Study Summary

The objective of this study is to see whether a home-use penile constriction device, Firmtech Tech Ring, can be determined to be superior to the Giddy device through evaluation of Leikert scale scores to assess ease of use and participant comfort and satisfaction with erectile quality with these devices. The primary outcome will be the satisfaction with use of the device as assessed through the Leikert scores. The other outcomes will be secondary.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All English-speaking participants > 18 years old recruited through social media.

  • Physically and emotionally capable of engaging in sexual activity with at least oneattempt per week of masturbation or sexual intercourse

Exclusion

Exclusion Criteria:

  • Men who cannot understand English.

  • Men with a prior or current penile implant.

  • Transgender or non-binary individuals

  • Men diagnosed with a hidden or buried penis.

  • Investigator's impression of expected poor participant compliance or anatomicinadequacy (penile size/girth)

  • Any psychiatric disorder, which, in the opinion of the investigator, would prohibitparticipation.

  • Coagulopathy or other blood disorder which the investigator determines would affectthe participant's participation in the trial.

  • Any tumor in the pelvic or penile region within the last 3 years

  • Men with an active caregiver who are unable to live independently.

  • Men who the provider is concerned would be at high risk for non-healing wounds ofthe penis.

  • Participants with sensory disorders like sensory processing disorder, sensoryintegration dysfunction disorder, neuropathies, etc.

Study Design

Total Participants: 51
Treatment Group(s): 2
Primary Treatment: FirmTech Tech Ring
Phase:
Study Start date:
May 02, 2023
Estimated Completion Date:
October 20, 2023

Connect with a study center

  • IVI RMA New Jersey

    Basking Ridge, New Jersey 07920
    United States

    Site Not Available

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