Gastric UlcerNCT01946633
Remote-controlled Capsule Endoscopy: a Feasibility Study
A study of Gastric Ulcer and Gastric Polyp, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
The present study is a feasibility study to assess the safety and efficacy of wireless capsule endoscope and compare the data obtained with those obtained by using a conventional esophagogastroduodenoscopy. The product was developed and manufacture in China.(the NaviCam. AKC-1.China) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Ulcer, Gastric Polyp
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Oct 2013to Sep 2014
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- upper abdominal symptoms (≥1 year )
- surveillance gastroscopy for known gastric ulcer or polyps
- history of gastric ulcer or polyps （≤1w）at Nanfang Hospital were enrolled.
Who cannot join
- dysphagia
- suspected or documented digestive tract malformation ,obstruction, strictures or fistula
- acute upper GI bleeding, acute enteritis, acute ischemia disease
- history of abdominal operations
- impaired renal function, congestive heart failure
- patients with critical condition or mental illness
Show all 9Show fewer
- patients with, known allergy to polymer material or antifoam agent
- patients with cardiac pacemakers or other implanted electromedical devices，magnetic resonance imaging ( mri) examination in 7 days
- pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Departement of Gastroenterology, Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Xinying Wang, Associate Professor, 86-020-61541540, sunwingwxy@163.com
About this study
The present study is a feasibility study to assess the safety and efficacy of wireless capsule endoscope and compare the data obtained with those obtained by using a conventional esophagogastroduodenoscopy.
The product was developed and manufacture in China.(the NaviCam. AKC-1.China)
- Conditions
- Gastric Ulcer, Gastric Polyp
- Being tested
- magnetic-controlled capsule endoscopy(Navicam)
- Medical subject headings
- Stomach Ulcer, Polyposis, Gastric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic-controlled capsule endoscopy(Navicam)Device
| Study group | Role | What they receive |
|---|---|---|
| Esophagogastroduodenoscopy（ECG） | Experimental | n=15 Receives: Device: magnetic-controlled capsule endoscopy(Navicam) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentage of complete visualization of anatomic landmarks
the percentage of patients in whom there was complete visualization of the gastric surface in the antrum, body, and fundus and identification of the cardia and pylorus
Measured: 2 year
examination time and the percentage of abnormal finding
examination time and the percentage of abnormal findings seen on gastroscopy that were reproducible by capsule endoscopy
Measured: 2 year
Secondary outcomes (2)
adverse effect
any discomfort like chest pain, nausea will be documented. capsule retention（defined as not extrusion in 14 days）will be documented.
Measured: 2 year
Acceptability
Acceptability to patients was assessed by means of a questionnaire, with ratings on a scale of 0 to 10 and examination chosen for next time. completed in the recovery room immediately after capsule examination.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric UlcerStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, xinying wang, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01946633
- Sponsor's protocol ID
- GNF-NaviCam-001
- Status last verified
- Oct 2013
- First submitted
- 12 Sep 2013
- Last updated
- 30 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Keller J, Fibbe C, Volke F, Gerber J, Mosse AC, Reimann-Zawadzki M, Rabinovitz E, Layer P, Schmitt D, Andresen V, Rosien U, Swain P. Inspection of the human stomach using remote-controlled capsule endoscopy: a feasibility study in healthy volunteers (with videos). Gastrointest Endosc. 2011 Jan;73(1):22-8. doi: 10.1016/j.gie.2010.08.053. Epub 2010 Nov 9.
PubMed 21067740
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote-controlled Capsule Endoscopy: a Feasibility Study
- ClinicalTrials.gov ID
- NCT01946633
- Acronym / sponsor ID
- GNF-NaviCam-001
- Conditions
- Gastric Ulcer, Gastric Polyp
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Sep 2014 (estimated)
- First posted
- 19 Sep 2013 (estimated)
- 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.
The present study is a feasibility study to assess the safety and efficacy of wireless capsule endoscope and compare the data obtained with those obtained by using a conventional esophagogastroduodenoscopy.
The product was developed and manufacture in China.(the NaviCam. AKC-1.China)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Esophagogastroduodenoscopy（ECG） | Experimental | Device: magnetic-controlled capsule endoscopy(Navicam)n=15 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- upper abdominal symptoms (≥1 year )
- surveillance gastroscopy for known gastric ulcer or polyps
- history of gastric ulcer or polyps （≤1w）at Nanfang Hospital were enrolled.
Key exclusion criteria (9 listed)
- dysphagia
- suspected or documented digestive tract malformation ,obstruction, strictures or fistula
- acute upper GI bleeding, acute enteritis, acute ischemia disease
- history of abdominal operations
- impaired renal function, congestive heart failure
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 |
|---|---|---|
| magnetic-controlled capsule endoscopy(Navicam) | Device | Esophagogastroduodenoscopy（ECG） |
Primary outcome
the percentage of complete visualization of anatomic landmarks
Time frame: 2 year
the percentage of patients in whom there was complete visualization of the gastric surface in the antrum, body, and fundus and identification of the cardia and pylorus
examination time and the percentage of abnormal finding
Time frame: 2 year
examination time and the percentage of abnormal findings seen on gastroscopy that were reproducible by capsule endoscopy
2 secondary outcomes
adverse effect
Time frame: 2 year
Acceptability
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2013.
- Background: PubMed 21067740Keller J, Fibbe C, Volke F, Gerber J, Mosse AC, Reimann-Zawadzki M, Rabinovitz E, Layer P, Schmitt D, Andresen V, Rosien U, Swain P. Inspection of the human stomach using remote-controlled capsule endoscopy: a feasibility study in healthy volunteers (with videos). Gastrointest Endosc. 2011 Jan;73(1):22-8. doi: 10.1016/j.gie.2010.08.053. Epub 2010 Nov 9.
- Inspection of the human stomach using remote-controlled capsule endoscopy: a feasibility study in healthy volunteersLink provided by the sponsor.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Gastric Ulcer and Gastric Polyp, run by Nanfang Hospital, Southern Medical University 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 9 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: status not confirmed, as of the sponsor's last update on 30 Oct 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xinying Wang, Associate Professor (86-020-61541540, sunwingwxy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the percentage of complete visualization of anatomic landmarks (time frame: 2 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01946633, which also lists 1 linked publication.
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 30 Oct 2013.