Clinical trial · Observational
Prospective Randomized Trial of Anterograde Single Balloon Versus Spirus Enteroscopy
Prospective Randomized Trial of Anterograde Single Balloon Versus Spirus Enteroscopy in Patients With Suspected Small Bowel Disease
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): SE system by Spirus Medical withdrawn from market in 2011
Summary
Brief summary (as posted)
The small bowel is poorly suited to standard endoscopy techniques due to its anatomical differences from the colon and the upper gastrointestinal tract. The small bowel has an average length of 6.7 m, with a free mesentery that resists standard "push to advance" endoscopy techniques. New developments in overtubes, which are placed over an enteroscope, have revolutionized doctors ability to deeply intubate the small bowel. Three types of 'augmented' enteroscopy, double balloon enteroscopy (DBE), single balloon enteroscopy (SBE) and spiral enteroscopy (SE), have been developed. Although studies have been performed on these individual techniques, there are no studies comparing SBE and SE, the two techniques used in Johns Hopkins. The investigators propose performing a prospective, randomised trial, to assess the differences between these two techniques. The question of what differences there are between these two techniques, in terms of depth of insertion, diagnostic and therapeutic yields, time required for the procedure and the sedation requirements, are important questions to answer, and depending on the results, would affect the investigators approach to patients with small bowel disease.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Hemorrhage | — | UNRESOLVED | — |
| Gastrointestinal Neoplasms | Digestive System Neoplasm | ALIAS | 0.90 |
| Inflammatory Bowel Disease | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Single Balloon | Procedure | — | UNRESOLVED |
| Spirus | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Single balloon
- description
- Single Balloon Enteroscopy
- interventionNames
- Procedure: Single Balloon
- label
- Spirus
- description
- Spirus Enteroscopy
- interventionNames
- Procedure: Spirus
Primary outcomes (1)
- measure
- Comparison of the depth of insertion into the small bowel of SBE compared with SE from the pylorus.
- timeFrame
- At the time of procedure
- description
- The depth of insertion was defined as the maximum distance the enteroscope was inserted past the pylorus. In SBE, the endoscopist estimates in 10cm increments from 0 to 40 cm the length of small bowel released during each insertion of the overtube and pulling back of the enteroscope and overtube. The net advancement is defined as the DMI for SBE. For SE the DMI is calculated by counting the length of bowel examined in 10-cm increments upon withdrawal of the enteroscope and overtube.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>18 years old * Referred to Johns Hopkins Hospital for anterograde augmented enteroscopy to assess for small bowel disease Exclusion Criteria: * Patients who are unable to give informed consent * Women who are pregnant * Inability to tolerate sedated endoscopy due to cardio-pulmonary instability or other contraindication to endoscopy * Patients who require retrograde enteroscopy as determined by the principle investigator * Patients with altered small bowel anatomy (i.e. Roux-en-Y anastomosis, Bilroth II anatomy) * Cirrhosis * Esophageal stricture * Uncorrected coagulopathy
References
Publications (9)
- BACKGROUNDHartmann D, Eickhoff A, Tamm R, Riemann JF. Balloon-assisted enteroscopy using a single-balloon technique. Endoscopy. 2007 Feb;39 Suppl 1:E276. doi: 10.1055/s-2007-966616. Epub 2007 Oct 24. No abstract available. PMID 17957636
- BACKGROUNDAkerman PA, Agrawal D, Cantero D, Pangtay J. Spiral enteroscopy with the new DSB overtube: a novel technique for deep peroral small-bowel intubation. Endoscopy. 2008 Dec;40(12):974-8. doi: 10.1055/s-0028-1103402. Epub 2008 Dec 8. PMID 19065477
- BACKGROUNDTsujikawa T, Saitoh Y, Andoh A, Imaeda H, Hata K, Minematsu H, Senoh K, Hayafuji K, Ogawa A, Nakahara T, Sasaki M, Fujiyama Y. Novel single-balloon enteroscopy for diagnosis and treatment of the small intestine: preliminary experiences. Endoscopy. 2008 Jan;40(1):11-5. doi: 10.1055/s-2007-966976. Epub 2007 Dec 4. PMID 18058613
- BACKGROUNDKawamura T, Yasuda K, Tanaka K, Uno K, Ueda M, Sanada K, Nakajima M. Clinical evaluation of a newly developed single-balloon enteroscope. Gastrointest Endosc. 2008 Dec;68(6):1112-6. doi: 10.1016/j.gie.2008.03.1063. Epub 2008 Jul 2. PMID 18599052
- BACKGROUNDAkerman PA, Cantero D. Spiral enteroscopy and push enteroscopy. Gastrointest Endosc Clin N Am. 2009 Jul;19(3):357-69. doi: 10.1016/j.giec.2009.04.001. PMID 19647645
- BACKGROUNDMehdizadeh S, Ross A, Gerson L, Leighton J, Chen A, Schembre D, Chen G, Semrad C, Kamal A, Harrison EM, Binmoeller K, Waxman I, Kozarek R, Lo SK. What is the learning curve associated with double-balloon enteroscopy? Technical details and early experience in 6 U.S. tertiary care centers. Gastrointest Endosc. 2006 Nov;64(5):740-50. doi: 10.1016/j.gie.2006.05.022. PMID 17055868
- BACKGROUNDHeine GD, Hadithi M, Groenen MJ, Kuipers EJ, Jacobs MA, Mulder CJ. Double-balloon enteroscopy: indications, diagnostic yield, and complications in a series of 275 patients with suspected small-bowel disease. Endoscopy. 2006 Jan;38(1):42-8. doi: 10.1055/s-2005-921188.