Peristeen Light Explorative Clinical Investigation

Coloplast

Status: Not yet enrolling

Conditions: Faecal Incontinence; Constipation - Functional

Treatments: Device: Peristeen Light - trans anal irrigation system

Study type: Interventional

Funder types: Industry

Identifiers

NCT07126327

CP378

Details and patient eligibility

About

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.

Full description

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 endpoint is bowel function measured on a 10 cm Visual Analog Scale (VAS) at Baseline Visit and end of Clinical Investigation visit.

Participants will use Peristeen Light for 12 weeks test period.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Exploratory single-arm interventional investigation

Experimental group

Description:

Prescription of Peristeen Light transanal irrigation system at enrolment to use for a 12 week test period

Treatment:

Device: Peristeen Light - trans anal irrigation system