Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
NCT ID:
NCT00731666
Eligibility Criteria:
Inclusion Criteria:
* Has an estimated life expectancy of more than 5 years
* Has been diagnosed with erectile dysfunction
* Is willing to have the Titan IPP implanted
* Is able and willing to complete all follow-up visits and procedures indicated in this protocol
* Has been informed of the nature of the study and agrees to its provisions and - Has provided written informed consent as approved by the Institutional Review board of the respective site
Exclusion Criteria:
* Participant has had a previous penile prosthesis or prior penile enlargement surgeries
* Participant has a compromised immune system
* Participant has had a myocardial infarction or coronary artery stent placement within 2 months prior to treatment
* Participant does not have manual dexterity or mental ability to operate the pump
* Participant has an active urogenital infection or active skin infection in region of surgery
* Participant is diagnosed with fibrotic disease, such as priapism or Peyronie's disease
* Participant is diagnosed with Chordee
* Participant has neuropathy
* Participant has a serious bleeding disorder or coagulopathy
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
25 Years
Maximum Age:
75 Years
Study:
NCT00731666
Study Brief:
Protocol Section:
NCT00731666