Insertability comparison of passive bending single-balloon prototype versus standard single-balloon enteroscopy: a...

Area of Science:

• Gastroenterology
• Endoscopy
• Medical Devices

Background:

• Traversing the ileocecal valve (ICV) retrogradely with single-balloon enteroscopy (SBE) presents technical challenges.
• Responsive insertion technology (RIT) colonoscopy was developed to enhance cecal intubation rates.
• A prototype long SBE equipped with RIT (P-SBE) was engineered for improved insertability.

Purpose of the Study:

• To compare the insertability of a standard SBE (S-SBE) versus a prototype SBE with RIT (P-SBE).
• To evaluate the efficacy of RIT in improving retrograde SBE procedures.

Main Methods:

• A multicenter, randomized, non-blinded trial involving 62 patients with small bowel pathologies.
• Procedures utilized SBE via the trans-anal route.
• Primary endpoint: time to stable terminal ileum (TI) intubation 20 cm beyond the ICV (TSTII). Success defined as intubation within 10 minutes.

Main Results:

• Sixty patients completed the study.
• TSTII was significantly shorter with P-SBE (98.3 seconds) compared to S-SBE (169.4 seconds) (P = 0.006).
• Completion rates for stable intubation within 10 minutes were 96.8% for P-SBE and 86.2% for S-SBE (P = 0.19).

Conclusions:

• Single-balloon enteroscopy integrated with responsive insertion technology demonstrates improved insertability.
• P-SBE facilitates more efficient traversal of the ileocecal valve during retrograde enteroscopy.
• RIT enhances the technical performance of SBE for small bowel examinations.