Small Bowel DiseaseNCT05086471
Performance Evaluation of the NaviCam SB Capsule Endoscope System for the Diagnosis of Small Bowel Diseases
A study testing NaviCam SB and PillCam SB3 in people with Small Bowel Disease, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Bowel Disease
- What is being tested?
- NaviCam SB and PillCam SB3
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteChina
- Study dates
- 23 Sep 2021to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Union Hospital, Tongji Medical College, Huazhong Univerdity of Science and Technology
Wuhan, Hubei, 430022
About this study
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
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.
Read the 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
- Being tested
- NaviCam SB, PillCam SB3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaviCam SBDevice
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 SB3Device
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: PillCam SB3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days
Secondary outcomes (5)
Intestinal transit time
The time from capsule swallowing to capsule excretion
Measured: 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.
Measured: 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.)
Measured: 14 days
Quality of small bowel images
Comparison of the quality of small intestine pictures taken with the two capsules
Measured: 14 days
Image reading time
Comparison of the reading times of the two capsules
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start23 Sep 2021
- Primary completion1 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Bowel DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Changhai Hospital, Qilu Hospital of Shandong University
- Responsible party
- Sponsor
- Investigators
- XiaoHua Hou, MD.PhD, Principal investigator, Union Hospital, Tongji Medical College, Huazhong Univerdity of Science and TechnologyRong Lin, MD.PhD, Principal investigator, Union Hospital, Tongji Medical College, Huazhong Univerdity of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05086471
- Sponsor's protocol ID
- NaviCam SB
- Status last verified
- Oct 2021
- First submitted
- 30 Sep 2021
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05086471
- Acronym / sponsor ID
- NaviCam SB
- Conditions
- Small Bowel Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Changhai Hospital, Qilu Hospital of Shandong University
- Study start
- 23 Sep 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 21 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NaviCam SB | Experimental | Device: NaviCam SBAfter 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. |
| PillCam SB3 | Other | Device: PillCam SB3After 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NaviCam SBSubjects 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. | Device | NaviCam SB |
| PillCam SB3Subjects 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. | Device | PillCam SB3 |
Primary outcome
Diagnostic agreement rate
Time frame: 14 days
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.
5 secondary outcomes
Intestinal transit time
Time frame: 14 days
Ease of swallowing the capsule
Time frame: 14 days
diagnosis rate
Time frame: 14 days
Quality of small bowel images
Time frame: 14 days
Image reading time
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
XiaoHua Hou, MD.PhD principal investigator
Union Hospital, Tongji Medical College, Huazhong Univerdity of Science and Technology
Rong Lin, MD.PhD principal investigator
Union Hospital, Tongji Medical College, Huazhong Univerdity of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NaviCam SB and PillCam SB3 in people with Small Bowel Disease, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic agreement rate (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.