The PowerSpiral Antegrade Investigational Device Exemption (IDE) Study

Small Bowel Disease Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03990207
• Other study ID #: 2018-OCA-01
• Status: Suspended
• Phase: N/A
• Start date: August 2022
• Est. completion date: October 2023

Study information

• Verified date: August 2022
• Source: Olympus Corporation of the Americas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate safety and efficacy

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 100
• Est. completion date: October 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intestinal Diseases
• Small Bowel Disease

Intervention

Device:
• PowerSpiral Enteroscopy System
Motorized spiral enteroscopy system

Locations

Country	Name	City	State
United States	Olympus Corporation of the Americas	Southborough	Massachusetts

Sponsors (6)

Lead Sponsor	Collaborator
Olympus Corporation of the Americas	AdventHealth, Baylor Research Institute, Rhode Island Hospital, University of Florida, University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

References & Publications (4)

Akerman PA, Haniff M. Spiral enteroscopy: prime time or for the happy few? Best Pract Res Clin Gastroenterol. 2012 Jun;26(3):293-301. doi: 10.1016/j.bpg.2012.03.008. Review. — View Citation

Baniya R, Upadhaya S, Subedi SC, Khan J, Sharma P, Mohammed TS, Bachuwa G, Jamil LH. Balloon enteroscopy versus spiral enteroscopy for small-bowel disorders: a systematic review and meta-analysis. Gastrointest Endosc. 2017 Dec;86(6):997-1005. doi: 10.1016/j.gie.2017.06.015. Epub 2017 Jun 23. Review. — View Citation

Buscaglia JM, Richards R, Wilkinson MN, Judah JR, Lam Y, Nagula S, Draganov PV. Diagnostic yield of spiral enteroscopy when performed for the evaluation of abnormal capsule endoscopy findings. J Clin Gastroenterol. 2011 Apr;45(4):342-6. doi: 10.1097/MCG.0b013e3181eeb74b. — View Citation

Khashab MA, Lennon AM, Dunbar KB, Singh VK, Chandrasekhara V, Giday S, Canto MI, Buscaglia JM, Kapoor S, Shin EJ, Kalloo AN, Okolo PI 3rd. A comparative evaluation of single-balloon enteroscopy and spiral enteroscopy for patients with mid-gut disorders. Gastrointest Endosc. 2010 Oct;72(4):766-72. doi: 10.1016/j.gie.2010.04.043. Epub 2010 Jul 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Total procedure time	Measured from initial enteroscope introduction through the bite block to final enteroscope withdrawal through the bite block in minutes.	Intraoperative
Secondary	Insertion time	Measured from the initial enteroscope introduction through the bite block to maximum depth of enteroscope insertion measured in minutes	Intraoperative
Secondary	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
Secondary	Total enteroscopy rate	Percentage of subjects where the entire small intestine is intubated with the enteroscopy from pylorus to cecum.	Intraoperative
Secondary	Diagnostic yield	Percentage of subjects where enteroscopy produces the findings required to establish diagnosis.	Intraoperative
Secondary	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
Secondary	Device deficiencies	Number of device deficiencies during the enteroscopy procedure	Intraoperative