GI Organ Tracking Via Balloon Applicators

NCT05471401 | Withdrawn DMC FDA Device

• 1 other identifier: 202207133
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

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

Keywords

Gastric balloon

Outcome Measures

Primary Outcomes (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 Outcomes (2)

• 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)

Study Arms (1)

Occlusion balloon catheter

EXPERIMENTAL

-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

Interventions

Balloon-tipped catheter DEVICE

Gastric balloon

Occlusion balloon catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Washington University School of Medicine: lead

Related Links

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

MeSH Terms

Conditions

Esophageal Neoplasms; Kidney Neoplasms; Laryngeal Neoplasms; Liver Neoplasms; Lung Neoplasms; Pancreatic Neoplasms; Stomach Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Otorhinolaryngologic Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases; Liver Diseases; Thoracic Neoplasms; Lung Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Stomach Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Hyun Kim, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: July 22, 2022
• Study Start: April 25, 2023
• Primary Completion: April 30, 2025
• Study Completion: May 31, 2025
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Contact investigator for details.
• Access Criteria: Contact investigator for details.