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 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT01920035
Eligibility Criteria:
Inclusion Criteria:
* Patient is male and a candidate for robotic assisted radical prostatectomy (RARP) for the treatment of prostate cancer
* Patient is over eighteen (\>18) years of age
* Patient reads, understands and speaks English fluently (U.S. Sites only)
* Subject understands and agrees to all pre-operative preparation procedures including a "self-administered" fleet enema
* Subject understands study procedures, risks of such procedures and is willing to comply with all study procedures
* Patient is willing and able to comply with all post-surgical milestones including completing and returning post-surgery follow up questionnaires at specified intervals over a 12 month period
* Subject agrees to participate in the study and is willing to sign the written informed consent per the enrolling site's institutional procedure
Exclusion Criteria:
* Presents with baseline or has a history of urinary incontinence
* Rectal or GI pathology deemed unsuitable for placement of the treatment device by the examining physician
* Prior extensive pelvic surgery such as low anterior resection, abdominoperineal resection, or proctocolectomy continent stool pouch, or any other extensive abdominopelvic surgery that would render the patient a high-risk for complications as deemed by the surgeon
* History of prior treatment of any kind for prostate cancer; e.g. radiation therapy, cryotherapy, high-intensity focused ultrasound (HIFU), hormonal or chemotherapy
* Prior intra-operative injuries (for example: rectal injury)
* Inadequate hemostasis
* Serious concurrent medical condition likely to result in death during the next 12 months. Any other acute or chronic condition which the Investigator believes will unacceptably increase the risk of study participation or interfere with study procedures and assessments.
* Active or recent (within 1 month prior to study enrollment) participation in another investigational clinical research study or planned to be enrolled in another study of prostate therapy.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01920035
Study Brief:
Protocol Section:
NCT01920035