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
NCT number | NCT03990207 |
Other study ID # | 2018-OCA-01 |
Secondary ID | |
Status | Suspended |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2022 |
Est. completion date | October 2023 |
Verified date | August 2022 |
Source | Olympus Corporation of the Americas |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate safety and efficacy
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 |
Country | Name | City | State |
---|---|---|---|
United States | Olympus Corporation of the Americas | Southborough | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Olympus Corporation of the Americas | AdventHealth, Baylor Research Institute, Rhode Island Hospital, University of Florida, University of Massachusetts, Worcester |
United States,
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
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 |
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