Small-Bowel DisordersPhase 4DBENCT01184690
Single-Operator Versus Dual-Operator Double-balloon Endoscopy in Patients With Small-Bowel Disorders
A Phase 4 study testing Single-operator double-balloon endoscopy and dual-operator double-balloon endoscopy in people with Small-Bowel Disorders, run by Shanghai Changzheng Hospital at 1 site in China.
Trial summary
Double-balloon endoscopy (DBE) is a new device that allows diagnosis and treatment throughout the entire small intestine. Although the originally described method requires two operators, the investigators have recently developed a method to perform DBE by a single operator. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Small-Bowel Disorders
- What is being tested?
- Single-operator double-balloon endoscopy and dual-operator double-balloon endoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Aug 2010to Aug 2011
- Phase
- Phase 4
- 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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- suspected or known small-bowel disease
- age: 16-70
Who cannot join
- pregnancy
- coagulation disorders
- prior surgery of the small bowel and colon
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai changzheng Hospital
Shanghai, Shanghai Municipality, 200003
About this study
Official title: Prospective Trial Comparing Single-Operator and Dual-Operator Double-balloon Endoscopy in Patients With Small-Bowel Disorders
Double-balloon endoscopy (DBE) is a new device that allows diagnosis and treatment throughout the entire small intestine. Although the originally described method requires two operators, the investigators have recently developed a method to perform DBE by a single operator. The investigators here assessed the clinical usefulness of this one-person method in comparison to the conventional two-person DBE.
- Conditions
- Small-Bowel Disorders
- Being tested
- Single-operator double-balloon endoscopy, dual-operator double-balloon endoscopy
- Keywords
- double-balloon endoscopy, diagnostic yield
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-operator double-balloon endoscopyProcedure or surgery
Single-operator double-balloon endoscopy
dual-operator double-balloon endoscopyProcedure or surgery
dual-operator double-balloon endoscopy
| Study group | Role | What they receive |
|---|---|---|
| Single-operator DBE | Active comparator | Single-operator double-balloon endoscopy Receives: Procedure: Single-operator double-balloon endoscopy |
| Dual-operator DBE | Active comparator | Dual-operator double-balloon endoscopy Receives: Procedure: dual-operator double-balloon endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
completion whether the complete enteroscopy is achieved?
The completion rate for examination of the entire small intestine
Measured: 2 hours
lesion-discovery
lesion-discovery rate
Measured: 2 hours
Secondary outcomes (2)
observation time
Measured: 2 hours
Number of Participants with Adverse Events
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2011 (estimated)
- Study completionAug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Small-Bowel DisordersStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jian Shi, MD, Principal investigator, Shanghai Changzheng HospitalBin Shi, MD, Principal investigator, Shanghai Changzheng HospitalWei-Fen Xie, MD, Study director, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01184690
- Sponsor's protocol ID
- DBE-S vs D
- Acronym
- DBE
- Status last verified
- Aug 2010
- First submitted
- 16 Aug 2010
- Last updated
- 19 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Araki A, Tsuchiya K, Okada E, Suzuki S, Oshima S, Okamoto R, Kanai T, Watanabe M. Single-operator method for double-balloon endoscopy: a pilot study. Endoscopy. 2008 Nov;40(11):936-8. doi: 10.1055/s-2008-1077545. Epub 2008 Sep 25.
PubMed 18819060Araki A, Tsuchiya K, Okada E, Suzuki S, Oshima S, Yoshioka S, Yoshioka A, Kanai T, Watanabe M. Single-operator double-balloon endoscopy (DBE) is as effective as dual-operator DBE. J Gastroenterol Hepatol. 2009 May;24(5):770-5. doi: 10.1111/j.1440-1746.2009.05787.x. Epub 2009 Feb 12.
PubMed 19220668
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Trial Comparing Single-Operator and Dual-Operator Double-balloon Endoscopy in Patients With Small-Bowel Disorders
- ClinicalTrials.gov ID
- NCT01184690
- Acronym / sponsor ID
- DBE / DBE-S vs D
- Conditions
- Small-Bowel Disorders
- Keywords
- double-balloon endoscopy, diagnostic yield
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 19 Aug 2010 (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.
Double-balloon endoscopy (DBE) is a new device that allows diagnosis and treatment throughout the entire small intestine. Although the originally described method requires two operators, the investigators have recently developed a method to perform DBE by a single operator. The investigators here assessed the clinical usefulness of this one-person method in comparison to the conventional two-person DBE.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-operator DBE | Active comparator | Procedure: Single-operator double-balloon endoscopySingle-operator double-balloon endoscopy |
| Dual-operator DBE | Active comparator | Procedure: dual-operator double-balloon endoscopyDual-operator double-balloon endoscopy |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- suspected or known small-bowel disease
- age: 16-70
Key exclusion criteria (3 listed)
- pregnancy
- coagulation disorders
- prior surgery of the small bowel and colon
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 |
|---|---|---|
| Single-operator double-balloon endoscopySingle-operator double-balloon endoscopy | Procedure or surgery | Single-operator DBE |
| dual-operator double-balloon endoscopydual-operator double-balloon endoscopy | Procedure or surgery | Dual-operator DBE |
Primary outcome
completion whether the complete enteroscopy is achieved?
Time frame: 2 hours
The completion rate for examination of the entire small intestine
lesion-discovery
Time frame: 2 hours
lesion-discovery rate
2 secondary outcomes
observation time
Time frame: 2 hours
Number of Participants with Adverse Events
Time frame: 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2010.
- Results publication: PubMed 18819060Araki A, Tsuchiya K, Okada E, Suzuki S, Oshima S, Okamoto R, Kanai T, Watanabe M. Single-operator method for double-balloon endoscopy: a pilot study. Endoscopy. 2008 Nov;40(11):936-8. doi: 10.1055/s-2008-1077545. Epub 2008 Sep 25.
- Results publication: PubMed 19220668Araki A, Tsuchiya K, Okada E, Suzuki S, Oshima S, Yoshioka S, Yoshioka A, Kanai T, Watanabe M. Single-operator double-balloon endoscopy (DBE) is as effective as dual-operator DBE. J Gastroenterol Hepatol. 2009 May;24(5):770-5. doi: 10.1111/j.1440-1746.2009.05787.x. Epub 2009 Feb 12.
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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.
Jian Shi, MD principal investigator
Shanghai Changzheng Hospital
Bin Shi, MD principal investigator
Shanghai Changzheng Hospital
Wei-Fen Xie, MD study director
Shanghai Changzheng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Single-operator double-balloon endoscopy and dual-operator double-balloon endoscopy in people with Small-Bowel Disorders, run by Shanghai Changzheng Hospital 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 2 inclusion and 3 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 19 Aug 2010. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
completion whether the complete enteroscopy is achieved? (time frame: 2 hours). 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 NCT01184690, which also lists 2 linked publications.
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 19 Aug 2010; AzTrials last refreshed its copy on 2 Nov 2026.