Esophageal CancerNCT05471401
GI Organ Tracking Via Balloon Applicators
A study testing Balloon-tipped catheter in people with Esophageal Cancer and Kidney Cancer, run by Washington University School of Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Kidney Cancer, Larynx Cancer
- What is being tested?
- Balloon-tipped catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 25 Apr 2023to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
About this study
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
- Being tested
- Balloon-tipped catheter
- Keywords
- Gastric balloon
- Medical subject headings
- Esophageal Neoplasms, Kidney Neoplasms, Laryngeal Neoplasms, Liver Neoplasms, Lung Neoplasms, Pancreatic Neoplasms, Stomach Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon-tipped catheterDevice
Gastric balloon
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Balloon-tipped catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who undergo successful inflation of the gastric balloon with oral contrast agent, with verification by MR or CT imaging
Measured: 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
Measured: 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.
Measured: Day of procedure (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start25 Apr 2023
- Primary completion30 Apr 2025 (estimated)
- Study completion31 May 2025 (estimated)
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hyun Kim, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05471401
- Sponsor's protocol ID
- 202207133
- Status last verified
- Jun 2024
- First submitted
- 19 Jul 2022
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data will be shared upon review and approval of request by the upper-GI focus group leaders at Siteman Cancer Center.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GI Organ Tracking Via Balloon Applicators
- ClinicalTrials.gov ID
- NCT05471401
- Acronym / sponsor ID
- 202207133
- Conditions
- Esophageal Cancer, Kidney Cancer, Larynx Cancer, Liver Cancer, Lung Cancer, Digestive Organs--Cancer
- Keywords
- Gastric balloon
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Low accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 22 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Occlusion balloon catheter | Experimental | Device: Balloon-tipped catheter-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balloon-tipped catheterGastric balloon | Device | Occlusion balloon catheter |
Primary outcome
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)
2 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
Time frame: Day of procedure (Day 1)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be shared upon review and approval of request by the upper-GI focus group leaders at Siteman Cancer Center.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyun Kim, M.D. principal investigator
Washington University School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Balloon-tipped catheter in people with Esophageal Cancer and Kidney Cancer, run by Washington University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.