Balloon-tipped catheter for Laryngeal Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Washington University School of Medicine, Saint Louis, MO
Laryngeal Cancer+17 More
Balloon-tipped catheter - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study 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.

Eligible Conditions

  • Laryngeal Cancer
  • Malignant Neoplasms
  • Malignant Neoplasm of Colon
  • Small Intestine Cancer
  • Rectal Carcinoma
  • Esophageal Neoplasms Malignant
  • Lung Cancers
  • Malignant Neoplasm of Stomach
  • Malignant Neoplasm of Pancreas
  • Renal Cancers
  • Liver Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Completion of follow-up for all participants (estimated to be 1 year)

Week 4
Number of grade grade ≥ 2 adverse events that are probably or definitely associated with the balloon inflation
Year 1
Percentage of participants who undergo successful inflation of the gastric balloon with oral contrast agent, with verification by MR or CT imaging
Day 1
Translation movement of stomach between CBCT scans with and without balloon insufflation

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Balloon-tipped catheter
1 of 1
Experimental Treatment

10 Total Participants · 1 Treatment Group

Primary Treatment: Balloon-tipped catheter · No Placebo Group · N/A

Balloon-tipped catheter
Device
Experimental Group · 1 Intervention: Balloon-tipped catheter · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: completion of follow-up for all participants (estimated to be 1 year)
Closest Location: Washington University School of Medicine · Saint Louis, MO
Photo of washington university school of medicine 1Photo of washington university school of medicine 2Photo of washington university school of medicine 3
2004First Recorded Clinical Trial
1 TrialsResearching Laryngeal Cancer
1465 CompletedClinical Trials

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,772 Previous Clinical Trials
2,269,718 Total Patients Enrolled
Hyun Kim, M.D.Principal InvestigatorWashington University School of Medicine
6 Previous Clinical Trials
216 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are scheduled to receive intra-thoracic or abdominal radiation therapy.
You are at least 18 years of age.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.