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The GentleWave Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02557152
Recruitment Status : Completed
First Posted : September 23, 2015
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Sonendo, Inc.

Brief 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.

Condition or disease Intervention/treatment
Root Canal Device: GentleWave System Treatment

Detailed 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration: 24 Months
Official Title: The GentleWave Post-Market Registry
Actual Study Start Date : September 2015
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018

Group/Cohort Intervention/treatment
Patients that were treated with the GentleWave System Device: GentleWave System Treatment



Primary Outcome Measures :
  1. Healing [ Time Frame: 24 months ]
    Radiographic analysis and clinical signs and symptoms at 24 months


Secondary Outcome Measures :
  1. Retreatment Rates [ Time Frame: 24 months ]
    Rate of retreatment at 24 months



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Up to 500 subjects that have been treated with the Sonendo GentleWave System.
Criteria

Inclusion Criteria:

  • One or more teeth treated with the Sonendo GentleWave System

Exclusion Criteria:

  • Institutionalized patients or prisoners

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02557152


Locations
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United States, California
Randy Garland, DDS
Encinitas, California, United States
SC Endododontics
Santa Ana, California, United States
Stacey Woo, DDS
Whittier, California, United States
Sponsors and Collaborators
Sonendo, Inc.
Investigators
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Study Director: Kim Bradbury Sonendo, Inc.
Additional Information:

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Responsible Party: Sonendo, Inc.
ClinicalTrials.gov Identifier: NCT02557152    
Other Study ID Numbers: CS-10
First Posted: September 23, 2015    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019