Swallowing FunctionNCT04862637
Detecting the Changes of Swallowing Function in Oral Cancer Patients
An observational study of Swallowing Function, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The evidence of swallowing changes in oral cancer patients is still limited. This study aimed to investigated the swallowing changes in these patients by using the videofluoroscopy (VFSS) and high resolution impedance manometry (HRIM). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Swallowing Function
- How many people
- 48 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Sep 2022to 11 Jun 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with the diagnosis of oral cancer
Who may be able to join
- patients elective received oral cancer surgery
Who cannot join
- 1. patients had major underlying disease, ex: heart, brain, lung, liver disease
- 2. coagulopathy
- 3.pregnancy
- 4. the patients could not have good compliance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using High Resolution Impedance Manometry (HRIM) Combined With Videofluoroscopic Swallow Study (VFSS) to Investigate the Changes of Swallowing Function in Oral Cancer Patients
The evidence of swallowing changes in oral cancer patients is still limited. This study aimed to investigated the swallowing changes in these patients by using the videofluoroscopy (VFSS) and high resolution impedance manometry (HRIM).
Read the detailed description
Objective: to investigated the swallowing changes in oral cancer patients by using the videofluoroscopy (VFSS) and high resolution impedance manometry (HRIM).
Methods: 1. patients are fulfilled tongue cancer diagnosis; 2.they will undergo VFSS and HRIM examinations before or after surgery if they experience discomfort while swallowing.
- Conditions
- Swallowing Function
- Keywords
- dysphagia, swallowing
- Medical subject headings
- Deglutition Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Bolus presence time
Lower value indicates shorter bolus presence in the pharynx
Measured: 15 minutes during the examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start15 Sep 2022
- Primary completion10 Jun 2025
- Study completion11 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Swallowing FunctionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 48 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862637
- Sponsor's protocol ID
- 202101035RIND
- Status last verified
- Sep 2025
- First submitted
- 21 Apr 2021
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: ethical concerns
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using High Resolution Impedance Manometry (HRIM) Combined With Videofluoroscopic Swallow Study (VFSS) to Investigate the Changes of Swallowing Function in Oral Cancer Patients
- ClinicalTrials.gov ID
- NCT04862637
- Acronym / sponsor ID
- 202101035RIND
- Conditions
- Swallowing Function
- Keywords
- dysphagia, swallowing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 10 Jun 2025 (actual)
- Study completion
- 11 Jun 2025 (actual)
- First posted
- 28 Apr 2021 (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 evidence of swallowing changes in oral cancer patients is still limited. This study aimed to investigated the swallowing changes in these patients by using the videofluoroscopy (VFSS) and high resolution impedance manometry (HRIM).
Detailed description
Objective: to investigated the swallowing changes in oral cancer patients by using the videofluoroscopy (VFSS) and high resolution impedance manometry (HRIM).
Methods: 1. patients are fulfilled tongue cancer diagnosis; 2.they will undergo VFSS and HRIM examinations before or after surgery if they experience discomfort while swallowing.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with the diagnosis of oral cancer
Key inclusion criteria (1 listed)
- patients elective received oral cancer surgery
Key exclusion criteria (4 listed)
- 1. patients had major underlying disease, ex: heart, brain, lung, liver disease
- 2. coagulopathy
- 3.pregnancy
- 4. the patients could not have good compliance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bolus presence time
Time frame: 15 minutes during the examination
Lower value indicates shorter bolus presence in the pharynx
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No. ethical concerns
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Swallowing Function, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Bolus presence time (time frame: 15 minutes during the examination). 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 19 Nov 2025.