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GI Organ Tracking Via Balloon Applicators

Primary Purpose

Esophageal Cancer, Kidney Cancer, Larynx Cancer

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Balloon-tipped catheter

About this trial

This is an interventional device feasibility trial for Esophageal Cancer focused on measuring Gastric balloon

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Washington University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Occlusion balloon catheter

Arm Description

-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.

Outcomes

Primary Outcome Measures

Percentage of participants who undergo successful inflation of the gastric balloon with oral contrast agent, with verification by MR or CT imaging

Secondary Outcome Measures

Number of grade grade ≥ 2 adverse events that are probably or definitely associated with the balloon inflation

Translation movement of stomach between CBCT scans with and without balloon insufflation

-Stomach position will be compared between interval scans.

Full Information

NCT ID

NCT05471401

First Posted

July 19, 2022

Last Updated

April 26, 2023

Sponsor

Washington University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT05471401

Brief Title

GI Organ Tracking Via Balloon Applicators

Official Title

GI Organ Tracking Via Balloon Applicators

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 25, 2023 (Actual)

Primary Completion Date

April 30, 2024 (Anticipated)

Study Completion Date

May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Cancer, Kidney Cancer, Larynx Cancer, Liver Cancer, Lung Cancer, Digestive Organs--Cancer, Intrathoracic--Cancer, Respiratory Organs--Cancer, Pancreas Cancer, Small Intestine Cancer, Stomach Cancer, Colon Cancer, Rectal Cancer

Keywords

Gastric balloon

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Occlusion balloon catheter

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Balloon-tipped catheter

Intervention Description

Gastric balloon

Primary Outcome Measure Information:

Title

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)

Secondary Outcome Measure Information:

Title

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)

Title

Translation movement of stomach between CBCT scans with and without balloon insufflation

Description

-Stomach position will be compared between interval scans.

Time Frame

Day of procedure (Day 1)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hyun Kim, M.D.

Phone

314-362-8502

kim.hyun@wustl.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hyun Kim, M.D.

Organizational Affiliation

Washington University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Washington University School of Medicine

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hyun Kim, M.D.

Phone

314-362-8502

kim.hyun@wustl.edu

First Name & Middle Initial & Last Name & Degree

Hyun Kim, M.D.

First Name & Middle Initial & Last Name & Degree

Chet Hammill, M.D.

First Name & Middle Initial & Last Name & Degree

Vladimir Kushnir, M.D.

First Name & Middle Initial & Last Name & Degree

Lauren Henke, M.D.

First Name & Middle Initial & Last Name & Degree

Shahed Badiyan, M.D.

First Name & Middle Initial & Last Name & Degree

Yi Huang, M.S.

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Links:

URL

http://www.siteman.wustl.edu

Description

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

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GI Organ Tracking Via Balloon Applicators

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