Status:
TERMINATED
A Clinical Investigation Evaluating Peristeen® Performance
Lead Sponsor:
Coloplast A/S
Conditions:
Neurogenic Bowel
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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, ...
Detailed Description
The Peristeen system is a non-surgical, FDA-cleared, Class II device for the treatment of patients with neu-rogenic bowel dysfunction (NBD) who have failed conservative bowel management treatment and ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 13 2024
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT05381610
Start Date
June 1 2022
End Date
February 13 2024
Last Update
February 15 2024
Active Locations (1)
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1
Atrium Health
Charlotte, North Carolina, United States, 28204