A Clinical Investigation Evaluating Peristeen® Performance (CP342)
Neurogenic Bowel
About this trial
This is an interventional treatment trial for Neurogenic Bowel
Eligibility Criteria
Inclusion Criteria:
- Have given written informed consent
Be diagnosed with neurogenic bowel dysfunction (NBD), plus:
- Neurogenic bowel dysfunction score (Appendix A) of 10 or higher, indicating moderate or severe NBD AND
- Documented failure to achieve adequate bowel management in the last 30-days using the standards of care regimen including medications that alter GI transit but is naïve* to LVE and Peristeen
NOTE: For this study only, subjects are required to be naive for statistical analyses purposes.
For Spinal Cord Injury Subjects Only: Is past or outside initial spinal cord shock window
- 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.
- 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)
- Be within 4 weeks of endoscopic polypectomy (includes biopsy and/or endoscopy)
- Have an implanted stimulation device of any kind.
- Have ischemic colitis
- Have chronic or complex diverticular disease (i.e., acute, severe, ulcerative, previous and/or abscess)
- Have history of colonic obstruction, structural diseases of the colon or ileus
- Are pregnant, planning on becoming pregnant, or breastfeeding
- Have known phthalate sensitivity, specifically dibutyl phthalate
- Are current user of Peristeen or Large Volume Enemas
- Chronically used Peristeen or Large Volume Enema in the past 2 years.
- Diagnosis of opioid-induced constipation and/or narcotic bowel syndrome.
- Have severe Cognitive or severe physical impairment that prevents the ability to administer Peristeen by themselves and/or lack of caregiver support to administer Peristeen administration.
- Have other individual factors, in the opinion of the physician/healthcare professional, in which participating is contraindicated.
- Participation in concomitant clinical trial.
Sites / Locations
- Atrium HealthRecruiting
Arms of the Study
Arm 1
Experimental
Neurogenic Bowel
This is a US-Only, early feasibility, Investigational Device Exemption - Non-Significant Risk (IDE-NSR), single-center, open label study evaluating the effects of Peristeen, compared to a LVE administered into the rectum. The subjects to be analysed will be subjects with : Neurogenic Bowel Dysfunction (NBD). The NBD cohort will be broken down into two phases: LVE and Peristeen. See Statistical section 10 for more infor-mation on cohort and sub-group analyses.