Detecting the Changes of Swallowing Function in Oral Canc... | NCT04862637

Studies
Detecting the Changes of Swallowing Function in Oral Cancer Patients

NCT04862637

Sponsor

National Taiwan University Hospital

Status

Completed

Last Update Posted

Nov 19, 2025Actual

Enrollment

48Actual

Phase

Not provided

Conditions

Swallowing Function

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2022Actual

Primary Completion Date

Jun 10, 2025Actual

Completion Date

Jun 11, 2025Actual

First Submitted Date

Apr 21, 2021

First Submission Date that Met QC Criteria

Apr 26, 2021

First Posted Date

Apr 28, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 16, 2025

Last Update Posted Date

Nov 19, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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).

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bolus presence time	Lower value indicates shorter bolus presence in the pharynx	15 minutes during the examination

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients elective received oral cancer surgery

Exclusion Criteria:

1. patients had major underlying disease, ex: heart, brain, lung, liver disease
2. coagulopathy
3.pregnancy
4. the patients could not have good compliance

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

patients with the diagnosis of oral cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital		Taipei	Taiwan	100	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

ethical concerns

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003680	Deglutition Disorders

Ancestor Terms

ID	Term
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D010608	Pharyngeal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided