NCT07126327 Peristeen Light Explorative Clinical Investigation
| NCT ID | NCT07126327 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Coloplast A/S |
| Condition | Faecal Incontinence |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-11-10 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-11-10 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this exploratory clinical investigation is to understand the clinical benefits of Peristeen Light in adult patients with faecal incontinence, chronic constipation and/or time-consuming bowel management procedures. The primary objective is to evaluate changes in bowel-function when using Peristeen Light. Participants will use Peristeen Light for 12 weeks test period.
Eligibility Criteria
Inclusion Criteria: * Has given written informed consent * Is at least 18 years old * Has full legal capacity * Is able (assessed by investigator) and willing to adhere to clinical investigational procedures during clinical investigation-al duration * Has access to and is able to use a smartphone * Has constipation and/or faecal incontinence based on one or more of the following symptoms during the last 3 month: Straining in more than 25% of defecations, lumpy stools (Bristol Stool Type 1 and 2) in more than 25% of defecations, sensation of incomplete evacuation in more than 25% of defecations, sensation of anorectal obstruction/blockage in more than 25% of defecations, need to use manual maneuvers to facilitate defecation in more than 25% of defecations, fewer than three spontaneous bowel movements per week, loose stools are rarely present without use of laxatives, recurrent uncontrolled passage of faecal material (other words to describe this could be: Soiling, leak-age, passive faecal incontinence of flatus, mucus and/or stool) * Is assessed (by investigator) to have a need for low-volume TAI minimum every other day Exclusion Criteria: * Is participating in any other clinical investigation during this investigation * Has previously completed this investigation * Is former or current user of transanal irrigation (low- and high volume) * Has known hypersensitivity towards the device used in the investigation * Is pregnant * Has known anal stenosis * Has active/recurrent colorectal cancer * Has had anastomotic colorectal surgery within the last 3 months * Has ischaemic colitis * Has active inflammatory bowel disease * Has acute diverticulitis or diverticular abscess * Has medicine induced constipation (e.g. due to opioids) * Has chronic diarrhea * Has bowel dysfunction due to neurogenic disorder(s) * Is in need of high-volume TAI (as estimated by investigator)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07126327 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Faecal Incontinence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07126327 currently recruiting?
Yes, NCT07126327 is actively recruiting participants. Contact the research team at dkmibc@coloplast.com for enrollment information.
Where is the NCT07126327 trial being conducted?
This trial is being conducted at Aarhus, Denmark, Bologna, Italy.
Who is sponsoring the NCT07126327 clinical trial?
NCT07126327 is sponsored by Coloplast A/S. The trial plans to enroll 60 participants.