Status:
WITHDRAWN
AspireAssist for Palliative Venting Gastrostomy in Malignant Bowel Obstruction Patients
Lead Sponsor:
Case Comprehensive Cancer Center
Conditions:
Malignant Small Bowel Obstruction
Malignant Gastric Outlet Obstruction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Individuals with cancer causing an intestinal or stomach obstruction often require gastric drainage to prevent symptoms of nausea, vomiting, and to prevent aspiration. This is often achieved by a naso...
Detailed Description
This multicentered study will enroll participants into two cohorts of (study and control groups). The study group will undergo AspireAssist gastrostomy tube placement and the control group will underg...
Eligibility Criteria
Inclusion
- Malignant (cancer of any type) gastric or small bowel obstruction referred to surgery for placement of a venting gastrostomy tube for gastric decompression
- Able to demonstrate the ability to use the AspireAssist prior to placement
Exclusion
- Those who are immobile and unable to at least sit up in bed to vent the gastrostomy tube.
- Undergoing placement of a gastrostomy tube for any other indication other than malignant small bowel or gastric outlet obstruction.
- Absolute contraindications to gastrostomy tube placement, such as occluding oral or esophageal tumors
Key Trial Info
Start Date :
February 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04375462
Start Date
February 1 2023
End Date
August 1 2023
Last Update
January 31 2023
Active Locations (1)
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1
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195