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

Small Bowel Disease Clinical Trial

Official title:

Performance Evaluation of the NaviCam SB Capsule Endoscope System in Comparison to the PillCam SB3 Capsule System for the Diagnosis of Small Bowel Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05086471
• Other study ID #: NaviCam SB
• Status: Completed
• Phase: N/A
• Start date: September 23, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: October 2021
• Source: Wuhan Union Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: December 30, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intestinal Diseases
• Small Bowel Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Union Hospital, Tongji Medical College, Huazhong Univerdity of Science and Technology	Wuhan	Hubei

Sponsors (3)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China	Changhai Hospital, Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic agreement rate	The diagnosis of subjects by the two types of small bowel capsule endoscopes through independent image reading, that is, the agreement between the two systems with respect to the diagnosis of normal or abnormal subject.	14 days
Secondary	Intestinal transit time	The time from capsule swallowing to capsule excretion	14 days
Secondary	Ease of swallowing the capsule	The subject's supervisor determines how easy it is to swallow the capsule and which of the following feelings is very easy, easy, moderate, difficult, or very difficult.	14 days
Secondary	diagnosis rate	Comparison of the diagnosis rate (examination results within one week before or after enrollment) with other standard mucosal imaging tools (upper GI endoscopy, enteroscopy, colonoscopy, etc.)	14 days
Secondary	Quality of small bowel images	Comparison of the quality of small intestine pictures taken with the two capsules	14 days
Secondary	Image reading time	Comparison of the reading times of the two capsules	14 days