NCT04648891

Brief Summary

This study aims to identify adjuvant methods to improve patient comfort during in-office laryngology procedures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 2, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
11 months until next milestone

Results Posted

Study results publicly available

May 23, 2024

Completed
Last Updated

May 23, 2024

Status Verified

April 1, 2024

Enrollment Period

1.9 years

First QC Date

November 24, 2020

Results QC Date

April 30, 2024

Last Update Submit

April 30, 2024

Conditions

Spasmodic Dysphonia

Keywords

Pain

Outcome Measures

Primary Outcomes (1)

  • Pain Experienced

    Measured on a Visual Analogue Scale where 0 = no pain and 10 = worst pain

    6 months

Secondary Outcomes (1)

  • Subject Preference

    6 months

Study Arms (3)

Control

NO INTERVENTION

Patients will receive standard of care laryngeal injection of Botox via a transcricothyroid approach without additional anesthesia

Lidocaine

EXPERIMENTAL

Patients will receive standard of care laryngeal injection of Botox via a transcricothyroid approach following subcutaneous injection of lidocaine (approximately 2 minutes before Botox injection).

Drug: Lidocaine

Vibrating Wand

EXPERIMENTAL

Patients will receive standard of care laryngeal injection of Botox via a transcricothyroid approach while using the vibrating wand.

Device: Vibrating wand

Interventions

LidocaineDRUG

Subcutaneous injection 0.5cc 2% in 1:100,000 epinephrine

Lidocaine
Vibrating wandDEVICE

a vibrating instrument held adjacent to the cricothyroid space

Vibrating Wand

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Spasmodic dysphonia with or without tremor
  • Receiving botox as treatment via a transcricothyroid approach

You may not qualify if:

  • \- Allergy to lidocaine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Arizona

Phoenix, Arizona, 85054, United States

Location

Related Links

MeSH Terms

Conditions

DysphoniaPain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Voice DisordersLaryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
David G. Lott, M.D.
Organization
Mayo Clinic
Lott.David@mayo.edu
480-342-2983

Study Officials

  • David Lott, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 24, 2020

First Posted

December 2, 2020

Study Start

August 1, 2021

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

May 23, 2024

Results First Posted

May 23, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)