GI Organ Tracking Via Balloon Applicators

June 10, 2024 updated by: Washington University School of Medicine
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Sub-Investigator:
          • Yi Huang, M.S.
        • Contact:
        • Principal Investigator:
          • Hyun Kim, M.D.
        • Sub-Investigator:
          • Lauren Henke, M.D.
        • Sub-Investigator:
          • Shahed Badiyan, M.D.
        • Sub-Investigator:
          • Chet Hammill, M.D.
        • Sub-Investigator:
          • Vladimir Kushnir, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Occlusion balloon catheter
-Each participant will have an embolectomy balloon that is FDA approved for peripheral and neurovasculature temporary occlusion placed by nose or mouth. Anatomical position of balloon will be verified by on-board MR or CT imaging in to assess feasibility of using a duodenal balloon in this population. Participants who are imaged on the MR treatment machine will also be imaged with 4 or 8 frame per second sagittal imaging to assess real-time stomach and balloon respiratory motion. Participants imaged on CT based imaging (i.e. Ethos/Halcyon ring gantry system) will have CBCTs acquired at timed intervals (approximately 5-10 minutes between scans). After imaging, the balloon will be deflated and removed at that time.
Device: Balloon-tipped catheter
Gastric balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants who undergo successful inflation of the gastric balloon with oral contrast agent, with verification by MR or CT imaging
Time Frame: Completion of follow-up for all participants (estimated to be 1 year)
Completion of follow-up for all participants (estimated to be 1 year)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of grade grade ≥ 2 adverse events that are probably or definitely associated with the balloon inflation
Time Frame: Completion of follow-up (estimated to be 4 weeks)
Completion of follow-up (estimated to be 4 weeks)
Translation movement of stomach between CBCT scans with and without balloon insufflation
Time Frame: Day of procedure (Day 1)
-Stomach position will be compared between interval scans.
Day of procedure (Day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Hyun Kim, M.D., Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2023

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

May 31, 2025

Study Registration Dates

First Submitted

July 19, 2022

First Submitted That Met QC Criteria

July 19, 2022

First Posted (Actual)

July 22, 2022

Study Record Updates

Last Update Posted (Actual)

June 13, 2024

Last Update Submitted That Met QC Criteria

June 10, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202207133

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared upon review and approval of request by the upper-GI focus group leaders at Siteman Cancer Center.

IPD Sharing Time Frame

Contact investigator for details.

IPD Sharing Access Criteria

Contact investigator for details.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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