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Device
Peristeen for Neurogenic Bowel (CP342 Trial)
N/A
Waitlist Available
Research Sponsored by Coloplast A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be diagnosed with neurogenic bowel dysfunction (NBD), plus:
Be at least 18 years of age and have full legal capacity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 days
Awards & highlights
CP342 Trial Summary
This trial will compare the Peristeen system to a large volume enema in terms of safety and efficacy in order to help establish US reimbursement for the Peristeen system.
Who is the study for?
This trial is for adults with moderate to severe neurogenic bowel dysfunction (NBD) who haven't found relief with standard treatments but haven't used Peristeen or large volume enemas before. Candidates should be able to comply with study procedures and have no history of certain gastrointestinal surgeries, conditions like inflammatory bowel disease, or sensitivity to dibutyl phthalate.Check my eligibility
What is being tested?
The clinical trial is assessing the effectiveness of the Peristeen system compared to traditional large volume enemas in managing NBD. It aims to provide scientific evidence on how Peristeen may offer a different approach for patients struggling with this condition.See study design
What are the potential side effects?
While specific side effects are not listed here, potential risks may include discomfort from using the system, possible irritation or reaction if sensitive to materials in the device, and general complications that can arise from enema use.
CP342 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with neurogenic bowel dysfunction.
Select...
I am 18 years or older and can legally make my own decisions.
Select...
I can follow the study rules, including not using any rectal treatments or medications.
CP342 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 72 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The differences in the scintigraphy images, i.e. percentage of fecal matter, will be compared between the LVE and Peristeen.
CP342 Trial Design
1Treatment groups
Experimental Treatment
Group I: Neurogenic BowelExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Peristeen
2015
N/A
~30
Find a Location
Logistics
Accomodation is reimbursed
Your expenses for accomodation during the trial will be reimbursed.
Who is running the clinical trial?
Coloplast A/SLead Sponsor
152 Previous Clinical Trials
14,663 Total Patients Enrolled
1 Trials studying Neurogenic Bowel
20 Patients Enrolled for Neurogenic Bowel
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My colorectal cancer is active or has come back.I have had a blockage in my colon or related issues.You have a medical device implanted in your body to provide stimulation.I have been diagnosed with ischemic colitis.I have been diagnosed with neurogenic bowel dysfunction.I am 18 years or older and can legally make my own decisions.I have a severe or complicated form of diverticular disease.You are allergic to a specific chemical called dibutyl phthalate.I have had severe issues with my heart rate or blood pressure.I have active inflammatory bowel disease or Crohn's disease.I have had radiation or chemotherapy targeting my abdomen/pelvis.I have constipation caused by opioid use or narcotic bowel syndrome.I had a polyp removal or biopsy through endoscopy within the last 4 weeks.I have been using Peristeen or large volume enemas regularly for the last 2 years.I have had a bowel perforation in the past.I have a narrowing in my anus or rectum.I have had surgery on my digestive system or related areas.I cannot use Peristeen by myself due to severe physical or cognitive issues and do not have someone to help me.I can follow the study rules, including not using any rectal treatments or medications.My current bowel management treatments haven't worked, but I haven't tried LVE or Peristeen.I have severe anal conditions like fissures, fistulas, or large hemorrhoids.
Research Study Groups:
This trial has the following groups:- Group 1: Neurogenic Bowel
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacancies still available to enroll in this trial?
"Affirmative. Clinicaltrials.gov displays that this medical trial, made public on June 1st 2022, is currently recruiting patients. It expects to recruit a total of 20 individuals from one centre."
Answered by AI
How expansive is the scale of this experiment, in terms of its subject pool?
"Confirmed. According to clinicaltrials.gov, this medical study which was first published on June 1st 2022 is actively seeking participants. In total, 20 individuals must be recruited from a single site in order for the trial to commence as planned."
Answered by AI
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