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Completed

NCT Number: NCT04573959

Validation of CapsoVision CapsoCam® SV-3 Capsule Endoscopy System

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.

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Key information

Conditions

Intestinal Disease Celiac Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Ulcer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CapsoVision, Inc.

Saratoga, California, 95070, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Capsule Endoscopy System

Primary outcomes

  1. Ability to capture images

    Time frame: 2 weeks

    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. Ability to download images

    Time frame: 2 weeks

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

  3. Diagnostic Quality of Images

    Time frame: 2 weeks

    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.

Sponsors and collaborators

Lead sponsor

Capso Vision, Inc.

Industry

Collaborators

  • Generic Devices Consulting, Inc.

Registry information

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Oct 5, 2020
Registry last updated
Oct 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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