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Procedure

AspireAssist device for Gastric Outlet Obstruction

N/A
Waitlist Available
Led By Alisan Fathalizadeh, MD
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 30 days
Awards & highlights

Study Summary

This trial will compare the quality of life for cancer patients who have a weight-loss device called the AspireAssist, to those who have a standard gastrostomy tube.

Eligible Conditions
  • Small Bowel Obstruction
  • Gastric Outlet Obstruction

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of tube related complications per day
Patient satisfaction and ease of use survey scores
Quality of life as measured by Edmonton Symptom Assessment System (ESAS)
Secondary outcome measures
Ability to eat/drink assessed via GOOSS
Number of ED visits or readmissions for tube related problems
Number of calls or office visits for nausea or tube related issues
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: AspireAssistExperimental Treatment4 Interventions
Gastrostomy tubes will be placed 1-2 days after enrollment. Questionnaires will be completed at 7 and 30 days, and the AspireAssist group will have a clinic visit at 7 days to have the skin-port placed. All participants will be placed on a diet consisting of liquids and soft foods to prevent clogging of the gastrostomy tube
Group II: Standard PEGActive Control4 Interventions
Gastrostomy tubes will be placed 1-2 days after enrollment. Questionnaires will be completed at 7 and 30 days All participants will be placed on a diet consisting of liquids and soft foods to prevent clogging of the gastrostomy tube

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor
452 Previous Clinical Trials
31,910 Total Patients Enrolled
Alisan Fathalizadeh, MDPrincipal InvestigatorCleveland Clinic, Case Comprehensive Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
AspireAssist for Palliative Venting Gastrostomy in Malignant Bowel Obstruction Patients
2023. "AspireAssist for Palliative Venting Gastrostomy in Malignant Bowel Obstruction Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04375462.
~0 spots leftby Apr 2025
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