GI Organ Tracking Via Balloon Applicators

Washington University School of Medicine

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Conditions

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

Interventions

Balloon-tipped catheterDEVICE

Gastric balloon

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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 Outcomes

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)

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

-Stomach position will be compared between interval scans.

Time frame: Day of procedure (Day 1)

Data from ClinicalTrials.gov

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