A Clinical Investigation Evaluating Peristeen® Performance
Stopped: Lack of enrollment - Sponsor decision
United States6 participantsStarted 2022-06-01
Plain-language summary
Peristeen has been on the market globally since 2006 and marketed in the US since 2012, and more than 10,000 patients worldwide have been using Peristeen, with over 3,000 patients in the US. However, the US reimbursement is not uniform, resulting in many patients suffering from NBD in sub-optimal bowel manage-ment. Therefore, this study will scientifically define and describe how the Peristeen system is different from a large volume enema.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Have given written informed consent
. Be diagnosed with neurogenic bowel dysfunction (NBD), plus:
. Be at least 18 years of age and have full legal capacity
. Be willing and able to comply with investigation procedures - includes ability to forgo any rectal stimulation, rectal therapies or rectally administered medications or treatments for the duration of the study
. Have a normal digital examination on file in the past 6 months.
. Anorectal manometry test and data on file within past 6 months.
. Successful balloon expulsion test on file within the past 6 months. (i.e., can expel the balloon in 120 seconds or less)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The differences in the scintigraphy images, i.e. percentage of fecal matter, will be compared between the LVE and Peristeen.
. In the opinion of the investigator, be an appropriate candidate for the study
Exclusion criteria
. Have history/episode of severe autonomic dysreflexia, bradycardia or tachycardia.
. History of bowel perforation
. Have known anal or colorectal stenosis
. Have active/recurrent colorectal cancer
. Have active inflammatory bowel disease and/or Crohn's disease
. Any of the following anal conditions: Anal fissure, anal fistula or third- or fourth-degree haemorrhoids
. Have any history of irradiation therapy or chemotherapy targeting the abdomen and/or pelvic region
. Have any history of gastrointestinal, anal, and/or colorectal surgery (i.e., appendectomy, tubal ligation or hysterectomy, hemorrhoidectomy, cholecystectomy, and/or hiatal hernia surgery, LARS, MACE)