Erectile Dysfunction (ED)UNITEDNCT07273773
Evaluation of the Rigicon Infla10® Inflatable Penile Prosthesis (IPP) for Erectile Dysfunction
A study testing Rigicon Infla10® Inflatable Penile Prosthesis (IPP) in people with Erectile Dysfunction (ED), run by Rigicon, Inc. at 4 sites in United States.
Trial summary
This study evaluates the long-term safety and effectiveness of the Rigicon Infla10® Inflatable Penile Prosthesis in patients with erectile dysfunction. The study follows patients implanted with the Rigicon Infla10® Pulse™ Dynamic Inflatable Penile Prosthesis for up to 3 years after implantation. Read more about this study
- Who is it for?
- Ages 22 years and older, men only
- Conditions the study is for
- Erectile Dysfunction (ED)
- What is being tested?
- Rigicon Infla10® Inflatable Penile Prosthesis (IPP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 4 sitesUnited States
- Study dates
- 26 Jan 2026to Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male ≥22 years of age.
- Diagnosed with erectile dysfunction (impotence).
- Agree to receive Infla10® three-piece IPP as an ED treatment.
- Willing to complete all protocol required for follow-up visits and tests.
Who cannot join
- Contraindication to general anesthesia.
- Known allergy or sensitivity to product materials as indicated in the device labeling.
- Previous penile prosthesis or prior enlargement surgeries
- Diagnosed penile sensory neuropathy.
- Patients who are receiving immunosuppressive drugs or have a history of kidney transplantation.
- Patients who are receiving chemotherapy at the time of enrolment.
Show all 21Show fewer
- Diagnosed with fibrotic disease, such as priapism or Peyronie's disease or Chordee.
- Compromised immune system, such as systemic lupus erythematosus, discoid lupus, or scleroderma.
- Uncontrolled diabetes (HbA1c ≥ 9.0% [≈75 mmol/mol], measured within 90 days prior to surgery.
- Bleeding disorder or coagulopathy that may in the judgment of the investigator preclude safe procedure.
- Active urogenital infection or active skin infection in region of surgery or systemic infection at the time of assessment.
- Clinically significant comorbidities or presence of unstable conditions (e.g. cardiovascular, lung, renal [serum creatinine > 2.0 mg/dl], hepatic, bleeding disorders, or metabolic impairment) that may confound the results of the study or in the judgment of the physician investigator preclude safe procedure.
- Lacking manual dexterity or mental abilities necessary to operate the device.
- Expected life expectancy < two years.
- Unwilling or unable to sign the Informed Consent.
- Unwilling or unable to comply with the follow-up study requirements.
- Psychogenic erectile dysfunction
- Currently participating in an investigational drug or another investigational device exemption (IDE) study.
- The cognitively challenged subjects and subjects with any cognitive disorder that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affects the ability to complete the study questionnaires.
- Incarcerated subjects
- Subjects who are currently using, or who have not previously attempted and failed, standard non-surgical ED therapies including oral or topical treatments.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Atlanta Cosmetic Urology
Atlanta, Georgia, 30305
- Recruiting
Perito Urology
Coral Gables, Florida, 33146
- Recruiting
Vitality Urology Institute
Houston, Texas, 77024
- Recruiting
The University of South Florida Board of Trustees / Tampa General Hospital
Tampa, Florida, 33606
About this study
Official title: Evaluation of the Rigicon Infla10® Inflatable Penile Prosthesis (IPP) A Prospective, Multicenter, Single-Arm Performance-Goal Study
This study evaluates the long-term safety and effectiveness of the Rigicon Infla10® Inflatable Penile Prosthesis in patients with erectile dysfunction. The study follows patients implanted with the Rigicon Infla10® Pulse™ Dynamic Inflatable Penile Prosthesis for up to 3 years after implantation.
Read the detailed description
Erectile dysfunction (ED) is a common male sexual dysfunction associated with a reduced quality of life for patients and their partners. Incidence of ED increases with age and is associated with depression, obesity, diabetes mellitus, hypertension, cardiovascular disease and benign prostatic hyperplasia. ED is diagnosed with symptoms of (1) inability to attain or sustain a penile erection during sexual activity and (2) a reduction of penile rigidity in >75% of sexual encounters during six months period. ED is estimated to affect approximately 52% of men in age of 40 to 70 years. It is projected in 2025, the worldwide ED prevalence of about 322 million. ED usually has organic causes, such as damage of arteries, smooth muscle and fibrous tissue. This results in impairment of blood flow to and from penis due to diabetes, renal disease, atherosclerosis and vascular disease.
Management of ED involves lifestyle modification, medical, surgical interventions, and possibly, in the future, tissue- engineering or cellular or gene therapy. Oral phosphodiesterase type 5 inhibitor (PDE5i), which works with sexual stimulation, is an effective medical therapy for ED with an excellent safety profile. Intracavernosal injection or topical application of vasoactive drugs have also been studied. The first inflatable penile prosthesis was introduced in 1973, and current models of inflatable penile prostheses include the AMS 700 series, and Coloplast Titan device. A patient-activated inflatable penile prosthesis (IPP) provides patients with a means to achieve dependable spontaneity for intercourse.
Rigicon has developed a three-piece inflatable penile prosthesis (IPP) (Infla10®) for the treatment of ED. This study is to assess the safety and effectiveness of the Rigicon IPP in treating ED. Clinical literature and preclinical testing, including biocompatibility, device validation and verification, and animal studies support the safety and efficacy of this device for the intended therapy.
- Conditions
- Erectile Dysfunction (ED)
- Being tested
- Rigicon Infla10® Inflatable Penile Prosthesis (IPP)
- Keywords
- Rigicon, Infla10, inflatable penile prosthesis, penile prosthesis, Dynamic, erectile dysfunction
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rigicon Infla10® Inflatable Penile Prosthesis (IPP)Device
Medical Device: Infla10® Pulse™ Dynamic Inflatable Penile Prosthesis
- Other Names: Inflatable Penile Prosthesis (IPP) Treatment: Erectile dysfunction
| Study group | Role | What they receive |
|---|---|---|
| Patients implanted with Infla10® Pulse™ Dynamic Inflatable Penile Prosthesis | Experimental | Male subjects 22 years of age and older who are implanted with an Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis for erectile dysfunction. Receives: Device: Rigicon Infla10® Inflatable Penile Prosthesis (IPP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary safety outcome is the proportion of participants free from any device- or procedure-related adverse event of CTCAE Grade ≥2 through 12 months post-procedure, graded per CTCAE v6.0 and IPP-specific mapping.
Success will be concluded if the two-sided 95 percent confidence interval (equivalently, one-sided 97.5 percent) for the 12-month proportion has its lower bound strictly greater than 0.90 as specified in the statistical plan.
Measured: 12 months
The primary effectiveness endpoint is a binary "pass" or "fail" objective axial rigidity test, assessed at 12 months.
The objective axial rigidity test will use a calibrated axial-rigidity device to measure vertical displacement of the fully inflated penis under a standardized 650-gram load. ≤15 mm displacement will be counted as a "pass".
Success will be concluded if the two-sided 95 percent confidence interval for the 12-month success proportion has its lower bound strictly greater than the pre-specified performance goal in the statistical plan.
Measured: 12 months
Secondary outcomes (4)
Percentage of patients free from revision or explant surgeries at 12 months.
This secondary endpoint will summarize "revision- or explant-free survival" using Kaplan-Meier methods, with participants without an event right-censored at last contact.
Measured: 12 months
International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score
The Erectile Function (EF) domain of the IIEF-15 questionnaire (Items 1-5 and 15) will be used to assess patient erectile function. Change from baseline in the EF domain total score will be reported at each time point. The questionnaire may be completed remotely via ePRO.
Scale / Range: 6-30 points Direction: Higher scores indicate better erectile function. Assessment Schedule: Baseline and Months 3, 6, 12, 18, 24, and 36.
Measured: Baseline (pre-implantation) and Months 3, 6, 12, 18, 24, and 36 post-implantation.
Rosenberg Self-Esteem Scale (RSES) Total Score
The 10-item Rosenberg Self-Esteem Scale (RSES) is a validated self-report instrument used to measure global self-worth by assessing positive and negative feelings about the self. The total RSES score will be used as a secondary endpoint to evaluate change in participant self-esteem and psychosocial well-being following device implantation.
Administration and scoring: Each item is rated on a 4-point Likert scale (1 = Strongly Disagree to 4 = Strongly Agree). Items 2, 5, 6, 8, and 9 are reverse scored. The total score ranges from 10 to 40, with higher scores indicating greater self-esteem.
Analysis: Change from baseline in total RSES score will be summarized at each time point as mean ± standard deviation with 95% confidence intervals, and formally tested within the pre-specified hierarchical secondary endpoint sequence.
Scale / Range: 10-40 points Direction: Higher scores indicate higher self-esteem (better outcome).
Measured: Baseline (pre-implantation) and Months 3, 6, 12, 18, 24, and 36 post-implantation.
Adverse Events
Descriptive tabulations by system organ class and preferred term, including device-relatedness and seriousness, and rates for typical post-IPP events categorized as AEs, SAEs, and UADEs.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start26 Jan 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile Dysfunction (ED)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rigicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273773
- Sponsor's protocol ID
- RC2025_UNITED
- Acronym
- UNITED
- Status last verified
- Dec 2025
- First submitted
- 26 Nov 2025
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Rigicon Infla10® Inflatable Penile Prosthesis (IPP) A Prospective, Multicenter, Single-Arm Performance-Goal Study
- ClinicalTrials.gov ID
- NCT07273773
- Acronym / sponsor ID
- UNITED / RC2025_UNITED
- Conditions
- Erectile Dysfunction (ED)
- Keywords
- Rigicon, Infla10, inflatable penile prosthesis, penile prosthesis, Dynamic, erectile dysfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Rigicon, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Jan 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 10 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the long-term safety and effectiveness of the Rigicon Infla10® Inflatable Penile Prosthesis in patients with erectile dysfunction. The study follows patients implanted with the Rigicon Infla10® Pulse™ Dynamic Inflatable Penile Prosthesis for up to 3 years after implantation.
Detailed description
Erectile dysfunction (ED) is a common male sexual dysfunction associated with a reduced quality of life for patients and their partners. Incidence of ED increases with age and is associated with depression, obesity, diabetes mellitus, hypertension, cardiovascular disease and benign prostatic hyperplasia. ED is diagnosed with symptoms of (1) inability to attain or sustain a penile erection during sexual activity and (2) a reduction of penile rigidity in >75% of sexual encounters during six months period. ED is estimated to affect approximately 52% of men in age of 40 to 70 years. It is projected in 2025, the worldwide ED prevalence of about 322 million. ED usually has organic causes, such as damage of arteries, smooth muscle and fibrous tissue. This results in impairment of blood flow to and from penis due to diabetes, renal disease, atherosclerosis and vascular disease.
Management of ED involves lifestyle modification, medical, surgical interventions, and possibly, in the future, tissue- engineering or cellular or gene therapy. Oral phosphodiesterase type 5 inhibitor (PDE5i), which works with sexual stimulation, is an effective medical therapy for ED with an excellent safety profile. Intracavernosal injection or topical application of vasoactive drugs have also been studied. The first inflatable penile prosthesis was introduced in 1973, and current models of inflatable penile prostheses include the AMS 700 series, and Coloplast Titan device. A patient-activated inflatable penile prosthesis (IPP) provides patients with a means to achieve dependable spontaneity for intercourse.
Rigicon has developed a three-piece inflatable penile prosthesis (IPP) (Infla10®) for the treatment of ED. This study is to assess the safety and effectiveness of the Rigicon IPP in treating ED. Clinical literature and preclinical testing, including biocompatibility, device validation and verification, and animal studies support the safety and efficacy of this device for the intended therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients implanted with Infla10® Pulse™ Dynamic Inflatable Penile Prosthesis | Experimental | Device: Rigicon Infla10® Inflatable Penile Prosthesis (IPP)Male subjects 22 years of age and older who are implanted with an Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis for erectile dysfunction. |
Who may qualify
- Ages
- 22 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male ≥22 years of age.
- Diagnosed with erectile dysfunction (impotence).
- Agree to receive Infla10® three-piece IPP as an ED treatment.
- Willing to complete all protocol required for follow-up visits and tests.
Key exclusion criteria (21 listed)
- Contraindication to general anesthesia.
- Known allergy or sensitivity to product materials as indicated in the device labeling.
- Previous penile prosthesis or prior enlargement surgeries
- Diagnosed penile sensory neuropathy.
- Patients who are receiving immunosuppressive drugs or have a history of kidney transplantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rigicon Infla10® Inflatable Penile Prosthesis (IPP)Medical Device: Infla10® Pulse™ Dynamic Inflatable Penile Prosthesis • Other Names: Inflatable Penile Prosthesis (IPP) Treatment: Erectile dysfunction | Device | Patients implanted with Infla10® Pulse™ Dynamic Inflatable Penile Prosthesis |
Primary outcome
The primary safety outcome is the proportion of participants free from any device- or procedure-related adverse event of CTCAE Grade ≥2 through 12 months post-procedure, graded per CTCAE v6.0 and IPP-specific mapping.
Time frame: 12 months
Success will be concluded if the two-sided 95 percent confidence interval (equivalently, one-sided 97.5 percent) for the 12-month proportion has its lower bound strictly greater than 0.90 as specified in the statistical plan.
The primary effectiveness endpoint is a binary "pass" or "fail" objective axial rigidity test, assessed at 12 months.
Time frame: 12 months
The objective axial rigidity test will use a calibrated axial-rigidity device to measure vertical displacement of the fully inflated penis under a standardized 650-gram load. ≤15 mm displacement will be counted as a "pass". Success will be concluded if the two-sided 95 percent confidence interval for the 12-month success proportion has its lower bound strictly greater than the pre-specified performance goal in the statistical plan.
4 secondary outcomes
Percentage of patients free from revision or explant surgeries at 12 months.
Time frame: 12 months
International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score
Time frame: Baseline (pre-implantation) and Months 3, 6, 12, 18, 24, and 36 post-implantation.
Rosenberg Self-Esteem Scale (RSES) Total Score
Time frame: Baseline (pre-implantation) and Months 3, 6, 12, 18, 24, and 36 post-implantation.
Adverse Events
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rigicon Infla10® Inflatable Penile Prosthesis (IPP) in people with Erectile Dysfunction (ED), run by Rigicon, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zeynep Tin Konukcu (888-202-9790, clinical@rigicon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary safety outcome is the proportion of participants free from any device- or procedure-related adverse event of CTCAE Grade ≥2 through 12 months post-procedure, graded per CTCAE v6.0 and IPP-specific mapping. (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.