Thyroid NoduleNCT03395925
Evaluation of the Thyroid Volume After Radiofrequency Ablation of Thyroid Nodules and Recurrent Thyroid
A study testing Celon Pro Surge in people with Thyroid Nodule, run by Olympus Surgical Technologies Europe at 1 site in Germany.
Trial summary
Thyroid nodules are among the common alterations of the thyroid. Depending on the detection method the prevalence is between 20% and 50%, whereas the incidence increases with improvement of ultrasonic technology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Nodule
- What is being tested?
- Celon Pro Surge
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- 10 Nov 2017to 30 Jan 2022
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must have given written (personally signed and dated) informed consent before completing any study-related procedures (i.e. any assessment or evaluation that would not have formed part of their normal medical care).
- The patient must be aged 18yrs or older.
- The patient must be able to understand, and be willing to comply with the requirements of the protocol
- The patient is not pregnant
- The patient has the diagnosis of benign thyroid nodules, struma diffusa, struma uninodosa, struma multinodosa, struma per magna, Thyroidea nodosa or Thyroidea multinodosa
- The patient rejected surgery The patient rejected sole radioiodine therapy
Who cannot join
- Malign nodules
- Pregnancy
- Pacemaker near the target issue (<4cm)
- Nerve stimulating device
- High fever
- Prosthesis for the inner ear
Trial locations and contacts
1 site in 1 country.
About this study
Thyroid nodules are among the common alterations of the thyroid. Depending on the detection method the prevalence is between 20% and 50%, whereas the incidence increases with improvement of ultrasonic technology. The CelonPro Surge bipolar coagulation electrode operated with the compatible power control unit and compatible tube pump is indicated for ablation and coagulation of soft tissue, including thermal inactivation and/or volume reduction of locally defined tissue areas, such as tumors and metastases.
The primary objective of the study is to assess the influence of radiofrequency ablation due to thyroid volume after 24 hours, 3 months, 6 months and 1 year.
- Conditions
- Thyroid Nodule
- Being tested
- Celon Pro Surge
- Keywords
- Thyroid Nodule, Bipolar coagulation electrode, radiofrequency ablation
- Medical subject headings
- Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celon Pro SurgeDevice
Also called Bipolar coagulation electrode, tissue heating and ablation
bipolar coagulation electrode intended for tissue heating
| Study group | Role | What they receive |
|---|---|---|
| Celon Pro Surge | Experimental | Ablation of thyroid tissue Receives: Device: Celon Pro Surge |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of the study is to demonstrate reduction of thyroid volume following radiofrequency ablation of thyroid tissue
The primary endpoint is the reduction of thyroid volume at 12-Month follow-up visit. A responder to the radiofrequency treatment is defined as a subject with any reduction of the thyroid volume.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start10 Nov 2017
- Primary completion30 Oct 2021 (estimated)
- Study completion30 Jan 2022 (estimated)
Why it stopped: Study was not started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NoduleStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olympus Surgical Technologies Europe
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hüdayi Korkusuz, Prof., Principal investigator, Goethe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03395925
- Sponsor's protocol ID
- CEL THYRO01
- Status last verified
- Dec 2022
- First submitted
- 17 Dec 2017
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Thyroid Volume After Radiofrequency Ablation of Thyroid Nodules and Recurrent Thyroid
- ClinicalTrials.gov ID
- NCT03395925
- Acronym / sponsor ID
- CEL THYRO01
- Conditions
- Thyroid Nodule
- Keywords
- Thyroid Nodule, Bipolar coagulation electrode, radiofrequency ablation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was not started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Olympus Surgical Technologies EuropeIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2017 (actual)
- Primary completion
- 30 Oct 2021 (estimated)
- Study completion
- 30 Jan 2022 (estimated)
- First posted
- 10 Jan 2018 (actual)
- 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.
Thyroid nodules are among the common alterations of the thyroid. Depending on the detection method the prevalence is between 20% and 50%, whereas the incidence increases with improvement of ultrasonic technology. The CelonPro Surge bipolar coagulation electrode operated with the compatible power control unit and compatible tube pump is indicated for ablation and coagulation of soft tissue, including thermal inactivation and/or volume reduction of locally defined tissue areas, such as tumors and metastases.
The primary objective of the study is to assess the influence of radiofrequency ablation due to thyroid volume after 24 hours, 3 months, 6 months and 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Celon Pro Surge | Experimental | Device: Celon Pro SurgeAblation of thyroid tissue |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The patient must have given written (personally signed and dated) informed consent before completing any study-related procedures (i.e. any assessment or evaluation that would not have formed part of their normal medical care).
- The patient must be aged 18yrs or older.
- The patient must be able to understand, and be willing to comply with the requirements of the protocol
- The patient is not pregnant
- The patient has the diagnosis of benign thyroid nodules, struma diffusa, struma uninodosa, struma multinodosa, struma per magna, Thyroidea nodosa or Thyroidea multinodosa
Key exclusion criteria (6 listed)
- Malign nodules
- Pregnancy
- Pacemaker near the target issue (<4cm)
- Nerve stimulating device
- High fever
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 |
|---|---|---|
| Celon Pro SurgeAlso: Bipolar coagulation electrode, tissue heating and ablationbipolar coagulation electrode intended for tissue heating | Device | Celon Pro Surge |
Primary outcome
The primary objective of the study is to demonstrate reduction of thyroid volume following radiofrequency ablation of thyroid tissue
Time frame: 1 year
The primary endpoint is the reduction of thyroid volume at 12-Month follow-up visit. A responder to the radiofrequency treatment is defined as a subject with any reduction of the thyroid volume.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
- Individual participant dataSharing planned: No
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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.
Hüdayi Korkusuz, Prof. principal investigator
Goethe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Celon Pro Surge in people with Thyroid Nodule, run by Olympus Surgical Technologies Europe at 1 site in Germany.
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 6 inclusion and 6 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: withdrawn, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 was withdrawn before enrolling participants, so there are no results.
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?
The primary objective of the study is to demonstrate reduction of thyroid volume following radiofrequency ablation of thyroid tissue (time frame: 1 year). 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 23 Dec 2022.