Peristeen Light Explorative Clinical Investigation | NCT07126327

Studies
Peristeen Light Explorative Clinical Investigation

NCT07126327

Sponsor

Coloplast A/S

Status

Recruiting

Last Update Posted

Apr 14, 2026Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Faecal Incontinence
Constipation - Functional

Interventions

Peristeen Light - trans anal irrigation system

Countries

Denmark
Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 10, 2025Actual

Primary Completion Date

Aug 1, 2026Estimated

Completion Date

Aug 1, 2026Estimated

First Submitted Date

Jun 27, 2025

First Submission Date that Met QC Criteria

Aug 13, 2025

First Posted Date

Aug 17, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2026

Last Update Posted Date

Apr 14, 2026Actual

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exploratory single-arm interventional investigation	Experimental	Prescription of Peristeen Light transanal irrigation system at enrolment to use for a 12 week test period	Device: Peristeen Light - trans anal irrigation system

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Peristeen Light - trans anal irrigation system	Device	Subjects naive to TAI will use Peristeen Light trans anal irrigation	Exploratory single-arm interventional investigation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bowel function measured on a 10 cm Visual Analog Scale (VAS) at Baseline Visit (V1) and End of Clinical Investigation Visit (V7).	0 cm = worst possible bowel function and 10 cm = best possible bowel function.	From enrollment to the end of treatment at week 12.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001526	Behavioral Symptoms