GI Organ Tracking Via Balloon Applicators

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05471401

Enrollment

Registered

2022-07-22

Start date

2023-04-25

Completion date

2025-05-31

Last updated

2024-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Gastric balloon

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.

Interventions

DEVICEBalloon-tipped catheter

Gastric balloon

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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).

Design outcomes

Primary

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	Completion of follow-up for all participants (estimated to be 1 year)

Secondary

Measure	Time frame	Description
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)	—
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026