Single-Operator Versus Dual-Operator Double-balloon Endoscopy in Patients With Small-Bowel Disorders (DBE)
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ClinicalTrials.gov Identifier: NCT01184690 |
Recruitment Status : Unknown
Verified August 2010 by Shanghai Changzheng Hospital.
Recruitment status was: Enrolling by invitation
First Posted : August 19, 2010
Last Update Posted : August 19, 2010
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Condition or disease | Intervention/treatment | Phase |
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Small-Bowel Disorders | Procedure: Single-operator double-balloon endoscopy Procedure: dual-operator double-balloon endoscopy | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Diagnostic |
Official Title: | Prospective Trial Comparing Single-Operator and Dual-Operator Double-balloon Endoscopy in Patients With Small-Bowel Disorders |
Study Start Date : | August 2010 |
Estimated Primary Completion Date : | August 2011 |
Estimated Study Completion Date : | August 2011 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Single-operator DBE
Single-operator double-balloon endoscopy
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Procedure: Single-operator double-balloon endoscopy
Single-operator double-balloon endoscopy |
Active Comparator: Dual-operator DBE
Dual-operator double-balloon endoscopy
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Procedure: dual-operator double-balloon endoscopy
dual-operator double-balloon endoscopy |
- 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
- observation time [ Time Frame: 2 hours ]
- Number of Participants with Adverse Events [ Time Frame: 2 days ]

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Ages Eligible for Study: | 16 Years to 70 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- suspected or known small-bowel disease
- age: 16-70
Exclusion Criteria:
- pregnancy
- coagulation disorders
- prior surgery of the small bowel and colon

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01184690
China, Shanghai | |
Shanghai changzheng Hospital | |
Shanghai, Shanghai, China, 200003 |
Principal Investigator: | Jian Shi, MD | Shanghai Changzheng Hospital | |
Principal Investigator: | Bin Shi, MD | Shanghai Changzheng Hospital | |
Study Director: | Wei-Fen Xie, MD | Shanghai Changzheng Hospital |
Responsible Party: | Jian Shi, Shanghai Changzheng Hospital |
ClinicalTrials.gov Identifier: | NCT01184690 |
Other Study ID Numbers: |
DBE-S vs D |
First Posted: | August 19, 2010 Key Record Dates |
Last Update Posted: | August 19, 2010 |
Last Verified: | August 2010 |
double-balloon endoscopy diagnostic yield |
Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |