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NCT05471401 Clinical Trial

GI Organ Tracking Via Balloon Applicators

Lung Cancer Clinical Trial

Official title:
GI Organ Tracking Via Balloon Applicators

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05471401
Other study ID # 202207133
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 25, 2023
Est. completion date May 31, 2025

Study information
Verified date March 2024
Source Washington University School of Medicine
Contact Hyun Kim, M.D.
Phone 314-362-8502
Email kim.hyun@wustl.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The hypothesis of this study is that an occlusion balloon catheter placed in the stomach via an oral or nasogastric route will be safe and permit tracking of the stomach during radiation therapy.

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date May 31, 2025
Est. primary completion date April 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Scheduled to receive intra-thoracic or abdominal radiation therapy. It is not required that the stomach be in the radiation field. - At least 18 years of age. - ECOG performance status = 1 - Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable). Exclusion Criteria: - Prior trauma or surgical intervention that would alter the anatomy of the upper airs (nasogastric route), esophagus or stomach. - Previous complete or partial surgical resection of the esophagus, stomach, or duodenum. - Presence of implantable devices (e.g., automatic internal cardiac defibrillator, cardiac or gastric pacemaker).

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Balloon-tipped catheter
Gastric balloon

Locations
Country Name City State
United States Washington University School of Medicine Saint Louis Missouri

Sponsors (1)
Lead Sponsor Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of participants who undergo successful inflation of the gastric balloon with oral contrast agent, with verification by MR or CT imaging Completion of follow-up for all participants (estimated to be 1 year)
Secondary Number of grade grade = 2 adverse events that are probably or definitely associated with the balloon inflation Completion of follow-up (estimated to be 4 weeks)
Secondary Translation movement of stomach between CBCT scans with and without balloon insufflation -Stomach position will be compared between interval scans. Day of procedure (Day 1)
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