Small Bowel Disease
Conditions
Brief summary
To evaluate safety and efficacy
Detailed description
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.
Interventions
DEVICEPowerSpiral Enteroscopy System
Motorized spiral enteroscopy system
Sponsors
Baylor Research Institute
University of Massachusetts, Worcester
University of Florida
AdventHealth
Rhode Island Hospital
Olympus Corporation of the Americas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is ≥ 22 years of age * Medical indication for antegrade enteroscopy * Willing and able to provide informed consent
Exclusion criteria
* Any medical contraindication to standard enteroscopy * Any test that is done as part of the standard of care that would prevent the enteroscopy from being performed for safety reasons * Unable or unwilling to provide informed consent * Female and of child-bearing age who is currently pregnant or planning to become pregnant within the study period * Presence of any intra-luminal or extra-luminal foreign body in the abdominal cavity * Any prior gastric, small bowel or colonic surgery, or implantable devices in these locations (cardiac pacemakers and non-abdominal implants are acceptable) * Known or suspected bowel obstruction, or history of bowel obstruction * Taking anti-platelet agents or anticoagulants (other than aspirin) within last 7 days * Known coagulation disorder * Known or suspected esophageal stricture or Schatzki ring * Known gastric or esophageal varices * Suspected perforation of the gastrointestinal (GI) tract * Previous abdominal radiation * Inability to tolerate general anesthesia for any reason * Inability to tolerate endotracheal intubation * Known need for endoscopic retrograde cholangiopancreatography (ERCP) during enteroscopy * American Society of Anesthesiologists (ASA) Classification 4 or greater
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of device related serious adverse events | 7 days | 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 |
| Maximum depth of endoscope insertion | Intraoperative | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Withdrawn time | Intraoperative | Measured from maximum depth of enteroscope insertion excluding any time spent on therapeutic interventions, to final enteroscope withdrawal through bite block measured in minutes. |
| Total enteroscopy rate | Intraoperative | Percentage of subjects where the entire small intestine is intubated with the enteroscopy from pylorus to cecum. |
| Total procedure time | Intraoperative | Measured from initial enteroscope introduction through the bite block to final enteroscope withdrawal through the bite block in minutes. |
| Adverse events | 7 days post-procedure | SAEs regardless of relationship to study device and/or procedure, and non-SAEs related to study device and/or procedure |
| Device deficiencies | Intraoperative | Number of device deficiencies during the enteroscopy procedure |
| Diagnostic yield | Intraoperative | Percentage of subjects where enteroscopy produces the findings required to establish diagnosis. |
| Insertion time | Intraoperative | Measured from the initial enteroscope introduction through the bite block to maximum depth of enteroscope insertion measured in minutes |
Countries
United States
Outcome results
None listed