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

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

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.

Study Overview

• Status: Completed
• Conditions: Small Bowel Disease
• Intervention / Treatment: Device: NaviCam SB; Device: PillCam SB3

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.

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Union Hospital, Tongji Medical College, Huazhong Univerdity of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Other: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intestinal transit time	The time from capsule swallowing to capsule excretion	14 days
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
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
Quality of small bowel images	Comparison of the quality of small intestine pictures taken with the two capsules	14 days
Image reading time	Comparison of the reading times of the two capsules	14 days

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China
• Collaborators: Changhai Hospital; Qilu Hospital of Shandong University
• Investigators: Principal Investigator: XiaoHua Hou, MD.PhD, Union Hospital, Tongji Medical College, Huazhong Univerdity of Science and Technology; Principal Investigator: Rong Lin, MD.PhD, Union Hospital, Tongji Medical College, Huazhong Univerdity of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2021
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: September 30, 2021
• First Submitted That Met QC Criteria: October 20, 2021
• First Posted (Actual): October 21, 2021

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases
• Other Study ID Numbers: NaviCam SB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No