Clinical trial NCT05086471: Performance Evaluation of the NaviCam SB Capsule Endoscope System for the Diagnosis of Small Bowel Diseases
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Small Bowel Disease
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
Collaborators: name: Changhai Hospital
name: Qilu Hospital of Shandong University
First posted: 2021-10-21
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Diagnostic agreement rate
timeFrame: 14 days
Secondary outcomes:
measure: Intestinal transit time
timeFrame: 14 days
measure: Ease of swallowing the capsule
timeFrame: 14 days
measure: diagnosis rate
timeFrame: 14 days
measure: Quality of small bowel images
timeFrame: 14 days
measure: Image reading time
timeFrame: 14 days
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong Univerdity of Science and Technology
state: Hubei
Study officials:
affiliation: Union Hospital, Tongji Medical College, Huazhong Univerdity of Science and Technology
name: XiaoHua Hou, MD.PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Union Hospital, Tongji Medical College, Huazhong Univerdity of Science and Technology
name: Rong Lin, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References: