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 range18 Years
SexALL
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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)
✓. 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.
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.
✕. 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)