Status:
UNKNOWN
Comparison Air Versus Carbon Dioxide Insufflation in Single Balloon Anterograde Enteroscopy
Lead Sponsor:
North Eastern Ohio Gastroenterology and Endoscopy center
Collaborating Sponsors:
Mercy Health Ohio
Conditions:
Carbon Dioxide Insufflation
Anterograde Single Balloon Enteroscopy
Eligibility:
All Genders
18-90 years
Brief Summary
Observation study comparing patient symptoms of bloating, pain, and nausea between CO2 insufflation vs. O2 insufflation in anterograde balloon enteroscopy.
Detailed Description
Study Subjects: Patients \>18 years of age who presented to North Eastern Ohio Gastroenterology and Associates and meet the indications for anterograde or retrograde balloon endoscopy. Indications in...
Eligibility Criteria
Inclusion
- All patients who presented to North Eastern Ohio Gastroenterology and Associates and meet the indications for anterograde single balloon endoscopy. Indications include small intestinal bleeding, evaluation of small bowel mass, or evaluation and treatment of small bowel strictures.
Exclusion
- Those who wish not to participate, pregnant patients, mentally disabled individuals, prisoners, patients who have long-term analgesic use (greater than 3 months) in the past 6 months from procedure date, or those patients deemed too high risk to undergo balloon endoscopy. High risk, defined as have 3 or more of the following risk factors: chronic obstructive pulmonary disease, renal failure, morbid obesity (BMI \> 40), immuno-suppression, acquired/concurrent infection, diabetes, and chronic steroid use.
Key Trial Info
Start Date :
January 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03811522
Start Date
January 1 2019
End Date
June 1 2020
Last Update
February 15 2019
Active Locations (1)
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1
St. Joesph Health Center
Warren, Ohio, United States, 44484