Faecal IncontinenceNCT07126327
Peristeen Light Explorative Clinical Investigation
A study testing Peristeen Light - trans anal irrigation system in people with Faecal Incontinence and Constipation - Functional, run by Coloplast A/S at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Faecal Incontinence, Constipation - Functional
- What is being tested?
- Peristeen Light - trans anal irrigation system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 10 Nov 2025to 2 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: An Explorative Clinical Investigation to Understand the Clinical Benefits of Peristeen Light
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.
Read the detailed 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.
- Conditions
- Faecal Incontinence, Constipation - Functional
- Being tested
- Peristeen Light - trans anal irrigation system
- Keywords
- trans anal irrigation
- Medical subject headings
- Encopresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peristeen Light - trans anal irrigation systemDevice
Subjects naive to TAI will use Peristeen Light trans anal irrigation
| Study group | Role | What they receive |
|---|---|---|
| Exploratory single-arm interventional investigation | Experimental | Prescription of Peristeen Light transanal irrigation system at enrolment to use for a 12 week test period Receives: Device: Peristeen Light - trans anal irrigation system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start10 Nov 2025
- Primary completion2 Sep 2026
- Study completion2 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Faecal IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07126327
- Sponsor's protocol ID
- CP378
- Status last verified
- Sep 2026
- First submitted
- 27 Jun 2025
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Explorative Clinical Investigation to Understand the Clinical Benefits of Peristeen Light
- ClinicalTrials.gov ID
- NCT07126327
- Acronym / sponsor ID
- CP378
- Conditions
- Faecal Incontinence, Constipation - Functional
- Keywords
- trans anal irrigation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 2 Sep 2026 (actual)
- Study completion
- 2 Sep 2026 (actual)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exploratory single-arm interventional investigation | Experimental | Device: Peristeen Light - trans anal irrigation systemPrescription of Peristeen Light transanal irrigation system at enrolment to use for a 12 week test period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peristeen Light - trans anal irrigation systemSubjects naive to TAI will use Peristeen Light trans anal irrigation | Device | Exploratory single-arm interventional investigation |
Primary outcome
Bowel function measured on a 10 cm Visual Analog Scale (VAS) at Baseline Visit (V1) and End of Clinical Investigation Visit (V7).
Time frame: From enrollment to the end of treatment at week 12.
0 cm = worst possible bowel function and 10 cm = best possible bowel function.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peristeen Light - trans anal irrigation system in people with Faecal Incontinence and Constipation - Functional, run by Coloplast A/S at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bowel function measured on a 10 cm Visual Analog Scale (VAS) at Baseline Visit (V1) and End of Clinical Investigation Visit (V7). (time frame: From enrollment to the end of treatment at week 12.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.