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

NCT05086471 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2023-09-18

No results posted yet for this study

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.

Conditions

  • Small Bowel Disease

Interventions

DEVICE

NaviCam SB

Subjects swallow two types of SB capsules approximately 40 minutes apart in a randomized order. During the capsule endoscopy, the doctor can view the small bowel images taken by the capsules in real time.

DEVICE

PillCam SB3

Subjects swallow two types of SB capsules approximately 40 minutes apart in a randomized order. During the capsule endoscopy, the doctor can view the small bowel images taken by the capsules in real time.

Sponsors & Collaborators

  • Changhai Hospital

    collaborator OTHER

  • Qilu Hospital of Shandong University

    collaborator OTHER

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    lead OTHER

Principal Investigators

  • XiaoHua Hou, MD.PhD · Union Hospital, Tongji Medical College, Huazhong Univerdity of Science and Technology

  • Rong Lin, MD.PhD · Union Hospital, Tongji Medical College, Huazhong Univerdity of Science and Technology

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-23
Primary Completion
2021-12-01
Completion
2021-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05086471 on ClinicalTrials.gov