Root CanalNCT02557152
The GentleWave Registry
An observational study of Root Canal, run by Sonendo, Inc. at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Root Canal
- What is being tested?
- GentleWave System Treatment
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2015to Jul 2018
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Up to 500 subjects that have been treated with the Sonendo GentleWave System.
Who may be able to join
- One or more teeth treated with the Sonendo GentleWave System
Who cannot join
- Institutionalized patients or prisoners
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Randy Garland, DDS
Encinitas, California
SC Endododontics
Santa Ana, California
Stacey Woo, DDS
Whittier, California
About this study
Official title: The GentleWave Post-Market Registry
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.
Read the 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.
- Conditions
- Root Canal
- Being tested
- GentleWave System Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GentleWave System TreatmentDevice
| Study group | Role | What they receive |
|---|---|---|
| Patients that were treated with the GentleWave System | Not described Receives: Device: GentleWave System Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing
Radiographic analysis and clinical signs and symptoms at 24 months
Measured: 24 months
Secondary outcomes (1)
Retreatment Rates
Rate of retreatment at 24 months
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root CanalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Sonendo, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kim Bradbury, Study director, Sonendo, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02557152
- Sponsor's protocol ID
- CS-10
- Status last verified
- Apr 2019
- First submitted
- 21 Sep 2015
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The GentleWave Post-Market Registry
- ClinicalTrials.gov ID
- NCT02557152
- Acronym / sponsor ID
- CS-10
- Conditions
- Root Canal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Sonendo, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2015 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 23 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients that were treated with the GentleWave System | – | Device: GentleWave System Treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Up to 500 subjects that have been treated with the Sonendo GentleWave System.
Key inclusion criteria (1 listed)
- One or more teeth treated with the Sonendo GentleWave System
Key exclusion criteria (1 listed)
- Institutionalized patients or prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GentleWave System Treatment | Device | Patients that were treated with the GentleWave System |
Primary outcome
Healing
Time frame: 24 months
Radiographic analysis and clinical signs and symptoms at 24 months
1 secondary outcome
Retreatment Rates
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim Bradbury study director
Sonendo, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Root Canal, run by Sonendo, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019.