The GentleWave Registry

Root Canal Clinical Trial

Official title:

The GentleWave Post-Market Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02557152
• Other study ID #: CS-10
• Status: Completed
• Start date: September 2015
• Est. completion date: July 2018

Study information

• Verified date: April 2019
• Source: Sonendo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this registry is to gain a real world perspective for the use and outcomes associated with the Sonendo® GentleWave System usage. The registry population includes up to 500 subjects that have been treated with the Sonendo GentleWave System at up to 25 clinical sites in the United States.

Description:

The purpose of this registry is to gain a real world perspective for the use and outcomes associated with the Sonendo® GentleWave System usage.

Up to 25 clinical sites in the United States. Up to 500 subjects that have been treated with the Sonendo GentleWave System. To assess outcomes for teeth treated with the GentleWave System in a commercial setting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• One or more teeth treated with the Sonendo GentleWave System

Exclusion Criteria:

• Institutionalized patients or prisoners

Related Conditions & MeSH terms

• Root Canal

Intervention

Device:
• GentleWave System Treatment

Locations

Country	Name	City	State
United States	Randy Garland, DDS	Encinitas	California
United States	SC Endododontics	Santa Ana	California
United States	Stacey Woo, DDS	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
Sonendo, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing	Radiographic analysis and clinical signs and symptoms at 24 months	24 months
Secondary	Retreatment Rates	Rate of retreatment at 24 months	24 months