FirmTech User Research Trial

Erectile Function Clinical Trial

Official title:

FirmTech User Research Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05853822
• Other study ID #: Firmtech_RMANJ_01
• Status: Recruiting
• Start date: May 2, 2023
• Est. completion date: June 2024

Study information

• Verified date: May 2023
• Source: Reproductive Medicine Associates of New Jersey
• Contact: Caroline Zuckerman, RN
• Phone: 19736562841
• Email: clinicalresearchteam[@]ivirma.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: June 2024
• Est. primary completion date: May 2024
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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 one attempt per week of masturbation or sexual intercourse

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 anatomic inadequacy (penile size/girth)
• Any psychiatric disorder, which, in the opinion of the investigator, would prohibit participation.
• Coagulopathy or other blood disorder which the investigator determines would affect the 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 of the penis.
• Participants with sensory disorders like sensory processing disorder, sensory integration dysfunction disorder, neuropathies, etc.

Related Conditions & MeSH terms

• Erectile Function

Intervention

Other:
• FirmTech Tech Ring
Participants will utilize the FirmTech Tech Ring at least twice during a two-week time period and complete a survey
• Giddy Penile Constriction Ring
Participants will utilize the Giddy Penile Constriction at least twice during a two-week time period and complete a survey

Locations

Country	Name	City	State
United States	IVI RMA New Jersey	Basking Ridge	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Reproductive Medicine Associates of New Jersey	FirmTech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device satisfaction via Leikert scores	A survey will be completed for each device after utilization	2 weeks after receiving device