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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04573959
Other study ID # CVI-006
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2015
Est. completion date June 11, 2020

Study information

Verified date September 2020
Source Capso Vision, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date June 11, 2020
Est. primary completion date June 11, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Device:
SV-3 Capsule Endoscopy
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.

Locations

Country Name City State
United States CapsoVision, Inc. Saratoga California

Sponsors (2)

Lead Sponsor Collaborator
Capso Vision, Inc. Generic Devices Consulting, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Ability to download images Images are correctly downloaded using the CapsoAccess Capsule Data Access System (CDAAS3). 2 weeks
Primary 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
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