Validation of CapsoVision CapsoCam® SV-3 Capsule Endoscopy System

NCT04573959 | Completed FDA Device

• 1 other identifier: CVI-006
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

To validate an updated version of CapsoCam® SV-3 Endoscopy System brand name CapsoCam Plus™) with respect to the reproducibility of the system to capture and download small bowel images in a manner consistent with the predicate CapsoCam® SV-2 and SV-3 capsule endoscopy systems.

Conditions

Intestinal Disease; Inflammatory Bowel Diseases; Crohn Disease; Ulcer; Celiac Disease

Keywords

Intestinal Disease; Inflammatory Bowel Diseases; Crohn Disease; Ulcer; Celiac Disease; Angioectasia; Polyp

Outcome Measures

Primary Outcomes (3)

• Ability to capture images

  Images are captured throughout an entire small bowel exam, with complete small bowel exam defined as the ability of the capsule to reach the cecum while still recording images.

  2 weeks

• Ability to download images

  Images are correctly downloaded using the CapsoAccess Capsule Data Access System (CDAAS3).

  2 weeks

• Diagnostic Quality of Images

  Small bowel images of diagnostic quality are able to be reviewed using the CapsoView CVV Software and determined to be effective for diagnostic purposes by the study investigator.

  2 weeks

Study Arms (1)

SV-3 Capsule Endoscopy

EXPERIMENTAL

CapsoCam SV-3 Capsule Endoscopy system will perform in a manner consistent with the performance of the CapsoCam SV-3 capsule endoscopy systems.

Device: SV-3 Capsule Endoscopy

Interventions

SV-3 Capsule Endoscopy DEVICE

The purpose of this study is to validate an updated version of the CapsoCam SV-3 Endoscopy System with respect to the reproducibility of the system to capture and download small bowel images in a manner consistent with the predicate CapsoCam SV-3 capsule endoscopy.

Also known as: Capsule Endoscopy System

SV-3 Capsule Endoscopy

Eligibility Criteria

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

You may qualify if:

• Male or Female
• Willing and able to provide written informed consent
• Completion of pre-study questionnaire
• Approval of study principal investigator

You may not qualify if:

• Subjects with abdominal pain of unknown origin
• Difficulty Swallowing
• Known or suspected gastrointestinal disease
• Diarrhea or constipation
• Anemia of unknown origin
• Rectal or other gastrointestinal bleeding
• Pregnancy

Sponsors & Collaborators

• Capso Vision, Inc.: lead
• Generic Devices Consulting, Inc.: collaborator

Study Sites (1)

CapsoVision, Inc.

Saratoga, California, 95070, United States

Location

MeSH Terms

Conditions

Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease; Ulcer; Celiac Disease; Polyps

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Malabsorption Syndromes; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• David Shields, MD

  CapsoVision Research Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: October 5, 2020
• Study Start: October 1, 2015
• Primary Completion: June 11, 2020
• Study Completion: June 11, 2020
• Last Updated: October 5, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)