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

NCT ID: NCT05086471

Last Updated: 2023-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-23
• Study Completion Date: 2021-12-30

Brief 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.

Detailed Description

This study adopts a prospective and self-controlled design. The subjects are adult patients (≥18 years old) who have symptoms of small bowel disease or suspected GI bleeding; 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. This study adopts a method of independent image reading in the participating centers. Two physicians of digestive endoscopy respectively review the images captured by the experimental capsule and the control capsule for normal versus abnormal findings, type of findings and categorization (lesions, polyps, bleeding, etc.), capsule transit time, reading time, and image quality.

Conditions

Small Bowel Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

NaviCam SB

After gastrointestinal preparation, the enrolled patients swallow NaviCam SB and the PillCam SB3 capsules approximately 40 minutes apart in a randomized order for small bowel capsule endoscopy.

Group Type: EXPERIMENTAL

NaviCam SB

Intervention Type: DEVICE

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.

PillCam SB3

After gastrointestinal preparation, the enrolled patients swallow NaviCam SB and the PillCam SB3 capsules approximately 40 minutes apart in a randomized order for small bowel capsule endoscopy.

Group Type: OTHER

PillCam SB3

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Adult patients (≥18 years old) who have symptoms of small bowel disease or suspected GI bleeding;

2. Those need capsule endoscopy because the recurring GI symptoms cannot be explained by other imaging methods;

3. Those can understand and accept this study protocol and voluntarily sign an informed consent.

Exclusion Criteria

1. Patient is expected to undergo MRI examination within 7 days after ingestion of the capsule;

2. Patient with known gastrointestinal motility disorders;

3. Patient with known or suspected gastrointestinal obstruction, stenosis or fistula;

4. Patient with known or suspected delayed gastric emptying;

5. Patient suffers from any condition, such as swallowing problems, which precludes compliance with study and/or device instructions;

6. Patient has any allergy or other known contraindication or intolerance to the medications used in the study;

7. Patient has any condition, which precludes compliance with study and/or device instructions;

8. Women who are either pregnant or nursing at the time of screening;

9. Concurrent participation in another clinical trial using any investigational drug or device;

10. Patient suffers from a life-threatening condition;

11. Patients with history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters;

12. Patients with pace-maker or implantable cardioverter other implantable electronic medical device;

13. Patient with an easily magnetized metal part;

14. Patient requires endoscopic placement of the capsule;

15. Others considered by the investigator not suitable for this study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changhai Hospital

OTHER

Sponsor Role: collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

XiaoHua Hou, MD.PhD

Role: PRINCIPAL_INVESTIGATOR

Union Hospital, Tongji Medical College, Huazhong Univerdity of Science and Technology

Rong Lin, MD.PhD

Role: PRINCIPAL_INVESTIGATOR

Union Hospital, Tongji Medical College, Huazhong Univerdity of Science and Technology

Locations

Union Hospital, Tongji Medical College, Huazhong Univerdity of Science and Technology

Wuhan, Hubei, China

Countries

China

Other Identifiers

NaviCam SB

Identifier Type: -

Identifier Source: org_study_id