|Title||Endoscopic stabilization device evaluation using IDEAL framework: A quality improvement study.|
|Publication Type||Journal Article|
|Year of Publication||2019|
|Authors||Sharma SK, Momose K, Sedrakyan A, Sonoda T, Sharaiha RZ|
|Journal||Int J Surg|
|Date Published||2019 Jul|
OBJECTIVE: To determine whether clinical evaluation reporting using the IDEAL (Idea, Development, Exploration, Assessment and Long-term study) framework improves a novel double-balloon endoscopic stabilization technology.
DESIGN: Observational registry 6 month study with no follow-up. Using the Prospective Development Study (PDS) format recommended by the IDEAL collaboration, we report on continued refinement and optimization of an endoscopic stabilization platform during a clinical study conducted by two clinicians from the first case onwards. Key outcomes (ability to reach cecum, inflation of balloons in the sigmoid and ascending colon, and complications) were prospectively reported for each patient sequentially. All changes to technique were highlighted, showing when they occurred and an explanation for the change.
RESULTS: 30 colonoscopies were undertaken using the device from April to September 2017. Two patients were excluded from the analysis for protocol deviations. Cecum was reached in 89% of the per protocol population of patients in an average time of 13.5 ± 11 min. Therapeutic zone creation was successful in 89% of patients on the right side of the intestine and 100% in those that reached the sigmoid. There were five deliberate changes in technique that occurred during the study that enabled improved device technical performance. There were no serious complications and one polyp was removed successfully using the device. Clinicians reported endoscope stability and increased visibility of the intestinal mucosa increased when using the device.
CONCLUSION: The IDEAL framework provided a structured reporting of the changes made to technique. Those changes facilitated a device that is safe, has achieved stability with improved performance.
|Alternate Journal||Int J Surg|
|Grant List||U01 FD005478 / FD / FDA HHS / United States|