CompletedNot Applicable

Performance Evaluation of the NaviCam SB Capsule Endoscope System for the Diagnosis of Small Bowel Diseases

China87 participantsStarted 2021-09-23

Plain-language summary

This study uses a comparative method to evaluate the performance of the NaviCam SB capsule endoscope system in comparison to the PillCam SB3 capsule system for the diagnosis of small bowel diseases.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Adult patients (≥18 years old) who have symptoms of small bowel disease or suspected GI bleeding;
✓. Those need capsule endoscopy because the recurring GI symptoms cannot be explained by other imaging methods;
✓. Those can understand and accept this study protocol and voluntarily sign an informed consent.

Exclusion criteria

✕. Patient is expected to undergo MRI examination within 7 days after ingestion of the capsule;
✕. Patient with known gastrointestinal motility disorders;
✕. Patient with known or suspected gastrointestinal obstruction, stenosis or fistula;
✕. Patient with known or suspected delayed gastric emptying;
✕. Patient suffers from any condition, such as swallowing problems, which precludes compliance with study and/or device instructions;
✕. Patient has any allergy or other known contraindication or intolerance to the medications used in the study;
✕. Patient has any condition, which precludes compliance with study and/or device instructions;
✕. Women who are either pregnant or nursing at the time of screening;

What they're measuring

Diagnostic agreement rate

Timeframe: 14 days

Trial details

NCT IDNCT05086471

SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-01

View on ClinicalTrials.gov More Small Bowel Disease trials