GI Organ Tracking Via Balloon Applicators

Sponsor
Washington University School of Medicine (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05471401
Collaborator
(none)
10
1
1
13
0.8

Study Details

Study Description

Brief Summary

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Device Feasibility
Official Title:
GI Organ Tracking Via Balloon Applicators
Anticipated Study Start Date :
Sep 30, 2022
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Oct 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Balloon-tipped catheter

-Each participant will have a gastric balloon 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

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. 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)]

  2. Translation movement of stomach between CBCT scans with and without balloon insufflation [Day of procedure (Day 1)]

    -Stomach position will be compared between interval scans.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Washington University School of Medicine Saint Louis Missouri United States 63110

Sponsors and Collaborators

  • Washington University School of Medicine

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT05471401
Other Study ID Numbers:
  • 20-x191
First Posted:
Jul 22, 2022
Last Update Posted:
Jul 22, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Keywords provided by Washington University School of Medicine
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 22, 2022