A Clinical Investigation Evaluating Peristeen® Performance

NCT05381610 | Terminated FDA Device

• 1 other identifier: CP342
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Neurogenic Bowel

Outcome Measures

Primary Outcomes (1)

• The differences in the scintigraphy images, i.e. percentage of fecal matter, will be compared between the LVE and Peristeen.

  The subject's fecal matter movement will be measured radiologically and the percent changes in both a large-volume enema and Peristeen treatment will be measured.

  72 days

Study Arms (1)

Neurogenic Bowel

EXPERIMENTAL

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.

Device: Peristeen

Interventions

Peristeen DEVICE

The Peristeen system will be handled by Coloplast trained personnel. The investigator and a trained nurse will participate in all the investigation related procedures. The nurse is trained in the handling of the investi-gational product as well as this is described in detail in the Instruction for Use (IFU). Subjects (and their caregivers, if appropriate) will also be trained on the use of Peristeen prior to independent use at home.

Neurogenic Bowel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

Atrium Health

Charlotte, North Carolina, 28204, United States

Location

MeSH Terms

Conditions

Neurogenic Bowel

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: May 19, 2022
• Study Start: June 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: February 13, 2024
• Last Updated: February 15, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)