Validation of CapsoVision CapsoCam® SV-3 Capsule Endoscopy System

C

Capso Vision

Status

Completed

Conditions

Intestinal Disease
Ulcer
Celiac Disease
Inflammatory Bowel Diseases
Crohn Disease

Treatments

Device: SV-3 Capsule Endoscopy

Study type

Interventional

Funder types

Industry

Identifiers

NCT04573959
CVI-006

Details and patient eligibility

About

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.

Full description

The purpose of the study is validate the an updated version of the 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. The system to be validated consists of an updated version of the CapsoCam® SV-3 video capsule endoscope, the CapsoView® CVV Software, the CapsoAccess ® Capsule Data Access System (CDAS3) and the CapsoRetrieve® Capsule Retrieval Kit for the collection of the excreted CapsoCam capsule. The captured CapsoCam® SV-3 capsule images of the small bowel will be downloaded via the CapsoAccess® Capsule Data Access System (CDAS3) to a computer and proprietary CapsoView® CVV Software is used to review capsule images. The CapsoView® software displays the video and employs a variety of image-enhancement, video playback, and image analysis features to facilitate physician review of the captured images. The software allows the physician to efficiently annotate individual frames from the video and compile a procedure report, which aids in diagnosis.

Enrollment

84 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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

Trial design

84 participants in 1 patient group

SV-3 Capsule Endoscopy
Experimental group
Description:
CapsoCam SV-3 Capsule Endoscopy system will perform in a manner consistent with the performance of the CapsoCam SV-3 capsule endoscopy systems.
Treatment:
Device: SV-3 Capsule Endoscopy

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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