To evaluate safety and efficacy
The purpose of this study is to evaluate the safety and efficacy of the PowerSpiral™ Enteroscopy System, when used in subjects undergoing antegrade (per-oral) enteroscopy of the small bowel.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
100
Motorized spiral enteroscopy system
Olympus Corporation of the Americas
Southborough, Massachusetts, United States
Rate of device related serious adverse events
The primary safety endpoint will compare the rate of device related serious adverse events (SAE) reported in this study to the rate of device related SAEs reported in medical literature for the Spirus Medical Endo-Ease Discovery™ SB overtube
Time frame: 7 days
Maximum depth of endoscope insertion
The primary efficacy endpoint will compare the maximum depth of enteroscope insertion for the study device to the maximum depth of enteroscope insertion data reported in medical literature for the Spirus Medical Endo-Ease Discovery™ SB overtube.
Time frame: Intraoperative
Total procedure time
Measured from initial enteroscope introduction through the bite block to final enteroscope withdrawal through the bite block in minutes.
Time frame: Intraoperative
Insertion time
Measured from the initial enteroscope introduction through the bite block to maximum depth of enteroscope insertion measured in minutes
Time frame: Intraoperative
Withdrawn time
Measured from maximum depth of enteroscope insertion excluding any time spent on therapeutic interventions, to final enteroscope withdrawal through bite block measured in minutes.
Time frame: Intraoperative
Total enteroscopy rate
Percentage of subjects where the entire small intestine is intubated with the enteroscopy from pylorus to cecum.
Time frame: Intraoperative
Diagnostic yield
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Percentage of subjects where enteroscopy produces the findings required to establish diagnosis.
Time frame: Intraoperative
Adverse events
SAEs regardless of relationship to study device and/or procedure, and non-SAEs related to study device and/or procedure
Time frame: 7 days post-procedure
Device deficiencies
Number of device deficiencies during the enteroscopy procedure
Time frame: Intraoperative