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A Clinical Investigation Evaluating Peristeen® Performance (CP342)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05381610
Recruitment Status : Recruiting
First Posted : May 19, 2022
Last Update Posted : July 7, 2022
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S

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.

Condition or disease Intervention/treatment Phase
Neurogenic Bowel Device: Peristeen Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
Official Title: A Clinical Investigation Evaluating Peristeen® Performance Characteristics of Scintigraphic Measurements in Patients With Neurogenic Bowel Dysfunction
Actual Study Start Date : June 1, 2022
Estimated Primary Completion Date : April 1, 2023
Estimated Study Completion Date : August 1, 2023

Arm Intervention/treatment
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.
Device: Peristeen
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.




Primary Outcome Measures :
  1. The differences in the scintigraphy images, i.e. percentage of fecal matter, will be compared between the LVE and Peristeen. [ Time Frame: 72 days ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Have given written informed consent
  2. 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

  3. Be at least 18 years of age and have full legal capacity
  4. 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
  5. Have a normal digital examination on file in the past 6 months.
  6. Anorectal manometry test and data on file within past 6 months.
  7. Successful balloon expulsion test on file within the past 6 months. (i.e., can expel the balloon in 120 seconds or less)
  8. In the opinion of the investigator, be an appropriate candidate for the study

Exclusion Criteria:

  1. Have history/episode of severe autonomic dysreflexia, bradycardia or tachycardia.
  2. History of bowel perforation
  3. Have known anal or colorectal stenosis
  4. Have active/recurrent colorectal cancer
  5. Have active inflammatory bowel disease and/or Crohn's disease
  6. Any of the following anal conditions: Anal fissure, anal fistula or third- or fourth-degree haemorrhoids
  7. Have any history of irradiation therapy or chemotherapy targeting the abdomen and/or pelvic region
  8. 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)
  9. Be within 4 weeks of endoscopic polypectomy (includes biopsy and/or endoscopy)
  10. Have an implanted stimulation device of any kind.
  11. Have ischemic colitis
  12. Have chronic or complex diverticular disease (i.e., acute, severe, ulcerative, previous and/or abscess)
  13. Have history of colonic obstruction, structural diseases of the colon or ileus
  14. Are pregnant, planning on becoming pregnant, or breastfeeding
  15. Have known phthalate sensitivity, specifically dibutyl phthalate
  16. Are current user of Peristeen or Large Volume Enemas
  17. Chronically used Peristeen or Large Volume Enema in the past 2 years.
  18. Diagnosis of opioid-induced constipation and/or narcotic bowel syndrome.
  19. 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.
  20. Have other individual factors, in the opinion of the physician/healthcare professional, in which participating is contraindicated.
  21. Participation in concomitant clinical trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05381610


Contacts
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Contact: Carri Browne 16123235772 dkcarr@coloplast.com

Locations
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United States, North Carolina
Atrium Health Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Jessica Kearney-Bryan, RN    704-355-0244    mailto:Jessica.kearney-bryan@atriumhealth.org   
Sponsors and Collaborators
Coloplast A/S
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Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT05381610    
Other Study ID Numbers: CP342
First Posted: May 19, 2022    Key Record Dates
Last Update Posted: July 7, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Neurogenic Bowel
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases