Development Study of Check-Cap Imaging System in Healthy Volunteers

NCT03989180 | Completed

• 1 other identifier: CL-SY-01-0092
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the performance of Check-Cap Imaging System in healthy volunteers in a variety of operating scenarios. The Back recorder unit is the primary module for evaluation The participants DO NOT ingest a capsule and the capsules do not have any radioactive source

Conditions

Colo-rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Performance of the C-Scan system in terms of communication between the C-Scan Capsule and the System Track in different locations, positions and configurations.

  The C-Scan System performance will be tested in different versions, configurations and locations. The C-Scan Cap with no radioactive source will be placed on the subject's abdomen and the C-Scan Track will be placed on the subject's back in different locations. The subject will be ask to continue his/her rutine daily activities such as: sleeping, driving a car, watching TV etc for a few days.

  36 months

Interventions

C-Scan System DEVICE

* Subjects will receive detailed instructions (verbally and written) about the normal operation of the recorder and how to handle it during normal daily routine. They will be asked to document all their daily activity in a personal diary (attached) * The recorder will be secured to their lower back to test its functionality

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The subject population in this study will be composed of male and female subjects older than 25 and younger than 75 years old that volunteer for the experiment and qualify with the inclusion / exclusion criteria A total of Thirty (30) subjects will be enrolled in this study. All study participants will fit the body dimensions listed below (inclusion criteria) Efforts will be made to maintain balanced numbers between men and women and even distribution of ages.

You may qualify if:

• Male or female between 20 and 75 years of age
• Subjects who are generally healthy
• Subjects who fit the following body dimensions:
• Height: 150-200 cm
• Weight : 50-140 Kg
• BMI: 20-35
• Subjects who are ready to follow the various physical activities such as: walking, running, sitting, driving, bending etc.
• Subjects who are free to spend up to 4 days carrying the back recorder system.
• Sign informed consent Form.

You may not qualify if:

• Subjects with cancer or other life threatening diseases or conditions
• Pregnant women
• Subjects with cardiac pacemaker or any other implanted or external portable medical device (i.e. infusion pumps)
• Bed-ridden or sedentary subjects
• Subjects who suffer significant movement limitations (who cannot follow the typical activities of walking, driving, bending, sitting etc.)
• Morbid Obesity (BMI \> 35)
• Subjects under custodial care
• Participation in current clinical study or clinical study within 30 days prior to the procedure

Sponsors & Collaborators

• Check-Cap Ltd.: lead

Study Sites (1)

Bnai-Zion Medical Center

Haifa, 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

  COO, VP R&D

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2019
• First Posted: June 18, 2019
• Study Start: January 6, 2016
• Primary Completion: December 6, 2020
• Study Completion: December 6, 2020
• Last Updated: February 17, 2022

Record last verified: 2022-02

Locations

IL (1)