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

INTERVENTION: 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 Concentration unit: Other Concentration type: up to Concentration number: 181‐ Trade Name: Eziclen/Izinova Product Name: Eziclen Product Code: A06AD10 Pharmaceutical Form: Concentrate for oral solution INN or Proposed INN: dqwe CAS Number: wewe Current Sponsor code: wewe Other descriptive name: SODIUM CHLORIDE Concentration unit: Other Concentration type: up to Concentration number: 181‐ Trade Name: Gastrografin Product Name: Gastografin Product Code: NDC 0270‐0445‐40 Pharmaceutical Form: Concentrate for oral solution INN or Proposed INN: dfw CAS Number: erer Current Sponsor code: ere Other descriptive name: SODIUM CHLORIDE Concentration unit: Other Concentration type: up to Concentration number: 181‐ CONDITION: 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 Classification code 10010029 Term: Colorectal cancer NOS System Organ Class: 100000004864 ; MedDRA version: 19.0 Level: LLT Classification code 10010024 Term: Colorectal cancer Duke's B1 System Organ Class: 100000004864 ; MedDRA version: 19.0 Level: LLT Classification code 10010025 Term: Colorectal cancer Duke's B2 System Organ Class: 100000004864 ; MedDRA version: 19.0 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 100000004864 ; MedDRA version: 19.0 Level: LLT Classification code 10010031 Term: Colorectal cancer stage B2 System Organ Class: 100000004864 Therapeutic area: Diseases [C] ‐ Cancer [C04] PRIMARY OUTCOME: Main Objective: The objective of the study is to establish which booster procedure best facilitates timely excretion of CCE. Primary end point(s): Excretion of the Colon Capsule into the toilet 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. 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 OUTCOME: 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 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