Which bowel preparation regime gives the most optimal Colon Capsule Endocscopy in patients with high risk polyps.

Optimizing Colon Capsule Endoscopy in follow up program on patients with colorectal polyps assessing three booster procedures for motility enhancement - CAREforCOLONbooster

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002237-30-DK

Enrollment

180

Registered

2016-07-11

Start date

2016-10-05

Completion date

Unknown

Last updated

2017-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endoscopic examination of the colon and rectum for polyps and cancers MedDRA version: 19.0 Level: LLT Classification code 10010026 Term: Colorectal cancer Duke's A System Organ Class: 100000004864 MedDRA version: 19.0 Level: LLT Classification code 10010027 Term: Colorectal cancer Duke's C System Organ Class: 100000004864 MedDRA version: 19.0 Level: LLT Classification code 10010028 Term: Colorectal cancer Duke's D System Organ Class: 100000004864 MedDRA version: 19.0 Level: LLT Classificatio

Interventions

Trade Name: Moviprep Product Name: Moviprep Pharmaceutical Form: Concentrate for oral solution INN or Proposed INN: ds CAS Number: sds Current Sponsor code: sds Other descriptive name: SODIUM CHLORIDE

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients in high risk of delopment of polyps in the colon or rectum because of previously presence of polyps larger than 10 mm and/or more than 3 polyps in one patient. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 180

Exclusion criteria

Exclusion criteria: Criteria for exclusion are: - Hypersensitivity to the active substances or one or more of the subsidiary substances, including o Phenylketonuri (due to aspartam in Moviprep®) o Glucose-6-phosphate-dehydrogenase deficiency (due to ascorbate in Moviprep®) - Gastrointestinal obstruction or perforation - Previous problems with bowel cleansing - Ileus - Toxic megacolon, which complicates serious inflammatoric conditions in the intestinal canal including Morbus Crohn and colitis ulcerosa - Serious (known) kidney disease - Previous surgery/resection of colon or rectum (except for appendectomy) - Pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of the study is to establish which booster procedure best facilitates timely excretion of CCE.;Secondary Objective: In addition, which booster procedure provides the highest level of bowel cleansing, alongside patient centered outcomes including satisfaction, compliance, and ability to manage CCE at home.;Primary end point(s): Excretion of the Colon Capsule into the toilet;Timepoint(s) of evaluation of this end point: Life time of the battery is about 14 hours before it runs out of electricity, so the end point will be evaluated after 14-16 hours after intake of the capsule	—

Measure

Time frame

Main Objective: The objective of the study is to establish which booster procedure best facilitates timely excretion of CCE.;Secondary Objective: In addition, which booster procedure provides the highest level of bowel cleansing, alongside patient centered outcomes including satisfaction, compliance, and ability to manage CCE at home.;Primary end point(s): Excretion of the Colon Capsule into the toilet;Timepoint(s) of evaluation of this end point: Life time of the battery is about 14 hours before it runs out of electricity, so the end point will be evaluated after 14-16 hours after intake of the capsule

—

Secondary

Measure	Time frame
Secondary end point(s): Secondarely, the cleansing of the intestine will be evaluated.;Timepoint(s) of evaluation of this end point: During the Colon Capsule Endoscopy and max 14 hours	—

Countries

Denmark

Contacts

Public ContactResearch Unit,Department of Surgery

OUH Odense University Hospital, Svendborg Sygehus

akd@rsyd.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026