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

NCT05086471 | Completed DMC

• 1 other identifier: NaviCam SB
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Small Bowel Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Intestinal transit time

  14 days

• Ease of swallowing the capsule

  14 days

• diagnosis rate

  14 days

• Quality of small bowel images

  14 days

• Image reading time

  14 days

Study Arms (2)

NaviCam SB

EXPERIMENTAL

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

PillCam SB3

OTHER

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

Interventions

NaviCam SB 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.

NaviCam SB

PillCam SB3 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (≥18 years old) who have symptoms of small bowel disease or suspected GI bleeding;
• Those need capsule endoscopy because the recurring GI symptoms cannot be explained by other imaging methods;
• Those can understand and accept this study protocol and voluntarily sign an informed consent.

You may not qualify if:

• Patient is expected to undergo MRI examination within 7 days after ingestion of the capsule;
• Patient with known gastrointestinal motility disorders;
• Patient with known or suspected gastrointestinal obstruction, stenosis or fistula;
• Patient with known or suspected delayed gastric emptying;
• Patient suffers from any condition, such as swallowing problems, which precludes compliance with study and/or device instructions;
• Patient has any allergy or other known contraindication or intolerance to the medications used in the study;
• Patient has any condition, which precludes compliance with study and/or device instructions;
• Women who are either pregnant or nursing at the time of screening;
• Concurrent participation in another clinical trial using any investigational drug or device;
• Patient suffers from a life-threatening condition;
• Patients with history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters;
• Patients with pace-maker or implantable cardioverter other implantable electronic medical device;
• Patient with an easily magnetized metal part;
• Patient requires endoscopic placement of the capsule;
• Others considered by the investigator not suitable for this study.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead
• Changhai Hospital: collaborator
• Qilu Hospital of Shandong University: collaborator

Study Sites (1)

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

Wuhan, Hubei, 430022, China

Location

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2021
• First Posted: October 21, 2021
• Study Start: September 23, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 30, 2021
• Last Updated: September 18, 2023

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)