Motility of the Check-cap's MD1 Colon Capsule in Subjects Following Colon Rectal Cancer Screening by Colonoscopy

NCT03785665 | Completed

• 1 other identifier: CL-MD1-01-0097
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

To monitor the Whole Gut Transit Time and repeatability of the motility of MD1 capsules in the colon of subjects with known polyps and in healthy subjects. Multi-Center, Open, Home Monitoring, Prospective Study. Up to 100 participants in various phases 2-5 capsules per person, (1 capsule at a time) The primary objective of the study is to monitor the variability of the motility of the MD1 capsules in the Gastrointestinal tract of human subjects with and without polyps in previous Colonoscopy.

Conditions

Colo-rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Measure the variability of the motility (Whole gut transit time from ingestion to excretion {hours}) of the MD1 (Motility dummy 1) capsules in the Gastrointestinal tract of human subjects with and w/out polyps in previous Colonoscopy.

  All participating subjects will be consented for multiple measurements. In selected subjects the experiment will be repeated with same type MD1 capsule but w/out the drug, to compare the effect of the drug on the motility and the instantaneous speed during contractions. These subjects will be selected according to their results in the first round, ease of adjustment to the monitoring routine, retrieval of the excreted capsules and lack of any side effects or complains. The repeated procedure will be at least 1 week apart and will be approved by the investigator only after positive identification of the excretion of the first capsule. Naturally, there is no need to repeat the colonoscopy procedure The repeated tests will be conducted according to the same protocol. There are no additional safety issues in the re-ingestions tests since the 1st capsule has to be excreted and retrieved few days before the repeated experiment starts

  12 months

Study Arms (1)

Participants

EXPERIMENTAL

All study participants will be examined by the MD1 capsules, 2-5 capsules per person, one capsule at a time. Efforts will be made to maintain balanced numbers between men and women and even distribution of ages

Device: MDI

Interventions

MDI DEVICE

Capsule MD1 (Motility dummy 1)

Also known as: Capsule MD1 (Motility dummy 1)

Participants

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female between 40 and 80 years of age
• Subjects which are generally healthy
• Subjects who were examined by colonoscopy during the previous 5 years period and can provide a copy of the report
• Subjects who are ready to undergo the monitoring routine and commit to at least two experiments
• Signed informed consent.

You may not qualify if:

• Subjects with advanced cancer or other life threatening diseases or conditions
• Subject with known history of dysphagia or other swallowing disorders
• Subject with known history of Gastrointestinal disease or symptoms, such as: Crohn's disease, Colitis, Inflammatory bowel disease (IBD), Meckel's Diverticulum, Bowen Hernia, Mega Colon, fistulas or other strictures (doctors' discretion).
• Subject with known motility disorder or Chronic Constipation (less than 3 bowel movements/week)
• Subject with known delayed gastric emptying
• Subject with prior history of abdominal surgery that might cause bowel strictures leading to capsule retention, as determined by physician discretion
• Subject with any condition believed to have an increased risk for capsule retention such as intestinal tumors, radiation enteritis, and incomplete colonoscopies due to obstructions or Nonsteroidal anti-inflammatory drugs (NSAID) enteropathy, as determined by physician discretion
• Subjects with known sensitivity to iodine, or with kidney failure
• Subjects with morbid obesity (Body Mass Index \> 35)
• Subjects with belly / girth circumference \> 125 cm
• Subject with any known condition which precludes compliance with study and/or device instructions
• Subject with known condition of drug abuse and/or alcoholism
• Women who are either pregnant or nursing at the time of screening (to be verified by test in case of woman of child-bearing potential that do not practice medically acceptable methods of contraception)
• Concurrent participation in another clinical trial using any investigational drug or device

Sponsors & Collaborators

• Check-Cap Ltd.: lead

Study Sites (1)

Bnai Zion Medical Center

Haifa, North, 33391, Israel

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Boaz Shpigelman

  VP R&D

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi-Center, Open, Home Monitoring, Prospective Study

Study Record Dates

• First Submitted: November 28, 2018
• First Posted: December 24, 2018
• Study Start: June 15, 2019
• Primary Completion: January 1, 2022
• Study Completion: January 11, 2022
• Last Updated: January 19, 2022

Record last verified: 2022-01

Locations

IL (1)