The PowerSpiral Antegrade Investigational Device Exemption (IDE) Study

Study Overview
=================
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.

Official Title
-----------------
A Prospective, Multicenter, Single-Arm, Pre-Market, Pivotal Study to Evaluate Safety and Efficacy of a Novel Motorized Spiral Enteroscope for Antegrade Enteroscopy

Conditions
-----------------
Small Bowel Disease

Intervention / Treatment
-----------------
* Device: PowerSpiral Enteroscopy System


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PowerSpiral Enteroscopy System<br>Subjects who have a medical indication for antegrade enteroscopy | Device: PowerSpiral Enteroscopy System<br>* Motorized spiral enteroscopy system<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total procedure time | Measured from initial enteroscope introduction through the bite block to final enteroscope withdrawal through the bite block in minutes. | Intraoperative | 
| Insertion time | Measured from the initial enteroscope introduction through the bite block to maximum depth of enteroscope insertion measured in minutes | 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. | Intraoperative | 
| Total enteroscopy rate | Percentage of subjects where the entire small intestine is intubated with the enteroscopy from pylorus to cecum. | Intraoperative | 
| Diagnostic yield | Percentage of subjects where enteroscopy produces the findings required to establish diagnosis. | Intraoperative | 
| Adverse events | SAEs regardless of relationship to study device and/or procedure, and non-SAEs related to study device and/or procedure | 7 days post-procedure | 
| Device deficiencies | Number of device deficiencies during the enteroscopy procedure | Intraoperative |