search
Back to results

Low-Cost, Portable Flexible Nasopharyngoscope in Head & Neck Cancers in Low Resource Settings - Optimization Phase

Primary Purpose

Head and Neck Cancer, Oral Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nasopharyngoscope
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Provide signed and dated informed consent form
  • Willing to comply with all study procedures and be available for the duration of the study
  • Male or female, aged 18 or older
  • Patients who clinical meet clinical criteria for rigid scope examination of the upper aerodigestive tract. This includes signs and symptoms such as dysphagia, nasal obstruction, neck mass, throat pain, and hoarseness.

Exclusion Criteria:

  • Subjects who have complications from the SOC rigid exam
  • Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
  • Withdrawal of consent during the study duration

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Active Comparator

Arm Label

Patients evaluated using flexible nasopharyngoscope prototype device

Patients evaluated using standard of care nasopharyngoscope

Providers using flexible nasopharyngoscope prototype device

Arm Description

Outcomes

Primary Outcome Measures

Number of providers who who reported the FNS is easy to use
Measured using a 5 point scale, with 1 = Very hard, 2=Harder, 3 = Same, 4= Easier and 5 = very easy

Secondary Outcome Measures

Rate of image quality of rigid scope
Measured using 5 point scale, with 1 being poor and 5 being excellent
Rate of image quality of flexible scope
Measured using 5 point scale, with 1 being poor and 5 being excellent
Number of patients who reported perceived pain following use of the flexible scope
Comparison using a 3 point scale, with 1 being much more and 3 being much less
Number of patients who experienced an adverse event following the use of the flexible scope
measured by a provider questionnaire following completion of flexible scope exam

Full Information

First Posted
May 24, 2021
Last Updated
October 3, 2023
Sponsor
Duke University
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
search

1. Study Identification

Unique Protocol Identification Number
NCT04905134
Brief Title
Low-Cost, Portable Flexible Nasopharyngoscope in Head & Neck Cancers in Low Resource Settings - Optimization Phase
Official Title
Partnership to Establish a Practice Based Network to Assess for Head and Neck Cancers Using a Low-Cost Portable Flexible Nasopharyngoscope - Optimization Phase
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
July 31, 2023 (Actual)
Primary Completion Date
September 22, 2023 (Actual)
Study Completion Date
September 22, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study aims to develop and evaluate a low-cost, portable, flexible nasopharyngeal scope (FNS) used to assess head and neck cancers (HNC) in low resource settings. The FNS will be compared to an endoscope that is used as standard of care (SOC) in terms of ease of use, image quality, and perceived pain. The ultimate goal is to compare the ease of use between the FNS to what is used in SOC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Oral Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients evaluated using flexible nasopharyngoscope prototype device
Arm Type
Active Comparator
Arm Title
Patients evaluated using standard of care nasopharyngoscope
Arm Type
No Intervention
Arm Title
Providers using flexible nasopharyngoscope prototype device
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Nasopharyngoscope
Intervention Description
Low-cost, flexible scope prototype will compared to standard of care scope used as standard of care.
Primary Outcome Measure Information:
Title
Number of providers who who reported the FNS is easy to use
Description
Measured using a 5 point scale, with 1 = Very hard, 2=Harder, 3 = Same, 4= Easier and 5 = very easy
Time Frame
up to 15 minutes
Secondary Outcome Measure Information:
Title
Rate of image quality of rigid scope
Description
Measured using 5 point scale, with 1 being poor and 5 being excellent
Time Frame
Day 1
Title
Rate of image quality of flexible scope
Description
Measured using 5 point scale, with 1 being poor and 5 being excellent
Time Frame
Day 1
Title
Number of patients who reported perceived pain following use of the flexible scope
Description
Comparison using a 3 point scale, with 1 being much more and 3 being much less
Time Frame
Day 1
Title
Number of patients who experienced an adverse event following the use of the flexible scope
Description
measured by a provider questionnaire following completion of flexible scope exam
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Willing and able to provide signed and dated informed consent form Willing to comply with all study procedures and be available for the duration of the study Male or female, aged 18 or older Patients who clinical meet clinical criteria for SOC scope examination of the upper aerodigestive tract. This includes signs and symptoms such as dysphagia, nasal obstruction, neck mass, throat pain, and hoarseness. Exclusion Criteria: Withdrawal of consent during the study duration Subjects who have complications from the SOC exam Anyone unable to under the SOC exam
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Lee, MD
Organizational Affiliation
Duke Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Low-Cost, Portable Flexible Nasopharyngoscope in Head & Neck Cancers in Low Resource Settings - Optimization Phase

We'll reach out to this number within 24 hrs