Study
Recruiting Not a phased study
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Wesley Hospital | Auchenflower | Australia | Recruiting |
| Canberra Laparoscopic, Robotic & Laser Urology Centre | Garran | Australia | Recruiting |
| Katelaris Urology | Hornsby | Australia | Recruiting |
| St George Urology | Hurstville | Australia | Recruiting |
| Advanced Urology Melbourne | Malvern | Australia | Recruiting |
| Shire Urology | Miranda | Australia | Recruiting |
| Urology South at Holmesglen Private Hospital | Moorabbin | Australia | Recruiting |
voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice
Who can join
The official eligibility criteria
Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.
Inclusion Criteria:
1. Male ≥22 years of age.
2. Diagnosed with erectile dysfunction (impotence).
3. Agree to receive Infla10® three-piece IPP as an ED treatment.
4. Willing to complete all protocol required follow-up visits and tests.
Exclusion Criteria:
1. Contraindication to general anesthesia.
2. Known allergy or sensitivity to product materials as indicated in the device labeling.
3. Previous penile prosthesis or prior enlargement surgeries
4. Diagnosed penile sensory neuropathy.
5. Diagnosed with fibrotic disease, such as priapism, Peyronie's disease or Chordee.
6. Compromised immune system, such as systemic lupus erythematosus, discoid lupus, or scleroderma
7. Patients who are receiving immunosuppressive drugs or have a history of kidney transplantation
8. Uncontrolled diabetes (Fasting Blood Sugar FBS) \>300 or HbA1c ≥9.0 on morning of surgery)
9. Bleeding disorder or coagulopathy that may in the judgment of the investigator preclude safe procedure.
10. Active urogenital infection or active skin infection in region of surgery or systemic infection at the time of assessment.
11. 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.
12. 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.
13. Lacking manual dexterity or mental abilities necessary to operate the device.
14. Expected life expectancy \< two years.
15. Unwilling or unable to sign the Informed Consent.
16. Unwilling or unable to comply with the follow-up study requirements.
17. Currently participating in an investigational drug or another investigational device exemption (IDE) study.
18. Incarcerated subjects
19. Psychogenic erectile dysfunction
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 13 August 2026.
- This page last checked by Voxsanity: 11 October 2026.
Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.
Not medical advice.
Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.
Letter for your doctor
A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.