Multinodular GoiterNCT01003652
Clinical Trial on Harmonic Focus Shears
An observational study of Multinodular Goiter, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The purpose of this study is to evaluate the technical benefits, advantages and limits of the use of the Harmonic Focus curved shears in total thyroidectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multinodular Goiter
- What is being tested?
- thyroidectomy
- Type of treatment
- Surgery or procedure
- How many people
- 68 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2008to Dec 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 68 patients candidate to total thyroidectomy for multinodular goiter in an academic hospital
Who may be able to join
- Total thyroidectomy for multinodular goiter in adults patients
Who cannot join
- Redo surgery, malignancy.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Brussels, 1200
About this study
Official title: Harmonic Focus Shears Versus Clamp-and-technique for Total Thyroidectomy
The purpose of this study is to evaluate the technical benefits, advantages and limits of the use of the Harmonic Focus curved shears in total thyroidectomy.
Read the detailed description
According to a randomized sequence, total thyroidectomy was performed in 34 patients using Harmonic Focus and in 34 patients using clamp-and-tie technique.
In this randomized prospective trial, differences in the duration of surgery, intraoperative bleeding and post-operative complications were analysed.
- Conditions
- Multinodular Goiter
- Being tested
- thyroidectomy
- Keywords
- goiter
- Medical subject headings
- Goiter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thyroidectomyProcedure or surgery
Comparison between two groups of patients. One group is operated on using harmonic Focus for haemostasis compared to a second group of patients operated on with the conventional haemostasis using tie-and-clamp technique
| Study group | Role | What they receive |
|---|---|---|
| Harmonic Focus /conventional haemostasis | Not described Receives: Procedure: thyroidectomy | |
| Harmonic Focus | Not described | |
| new surgical device | Not described | |
| Harmonic Focus / conventional haemostasis | Harmonic Focus group refers to the use of ultracision shears for haemostasis and conventional haemostasis group refers to the tie-and-clamp technique in total thyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy, safety and potential advantages of Harmonic Focus for total thyroidectomy
Measured: day one after surgery
Secondary outcomes (1)
Impact on bleeding, operative time, instrument exchanges, material needed for haemostasis
Measured: during the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2009 (estimated)
- Study startJan 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multinodular GoiterStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel Mourad, MD, PhD, Principal investigator, St Luc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01003652
- Sponsor's protocol ID
- St Luc
- Status last verified
- Jul 2019
- First submitted
- 27 Oct 2009
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harmonic Focus Shears Versus Clamp-and-technique for Total Thyroidectomy
- ClinicalTrials.gov ID
- NCT01003652
- Acronym / sponsor ID
- St Luc
- Conditions
- Multinodular Goiter
- Keywords
- goiter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 29 Oct 2009 (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 study is to evaluate the technical benefits, advantages and limits of the use of the Harmonic Focus curved shears in total thyroidectomy.
Detailed description
According to a randomized sequence, total thyroidectomy was performed in 34 patients using Harmonic Focus and in 34 patients using clamp-and-tie technique.
In this randomized prospective trial, differences in the duration of surgery, intraoperative bleeding and post-operative complications were analysed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Harmonic Focus /conventional haemostasis | – | Procedure: thyroidectomy |
| Harmonic Focus | – | – |
| new surgical device | – | – |
| Harmonic Focus / conventional haemostasis | – | –Harmonic Focus group refers to the use of ultracision shears for haemostasis and conventional haemostasis group refers to the tie-and-clamp technique in total thyroidectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 68 patients candidate to total thyroidectomy for multinodular goiter in an academic hospital
Key inclusion criteria (1 listed)
- Total thyroidectomy for multinodular goiter in adults patients
Key exclusion criteria (1 listed)
- Redo surgery, malignancy.
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 |
|---|---|---|
| thyroidectomyComparison between two groups of patients. One group is operated on using harmonic Focus for haemostasis compared to a second group of patients operated on with the conventional haemostasis using tie-and-clamp technique | Procedure or surgery | Harmonic Focus /conventional haemostasis |
Primary outcome
Efficacy, safety and potential advantages of Harmonic Focus for total thyroidectomy
Time frame: day one after surgery
1 secondary outcome
Impact on bleeding, operative time, instrument exchanges, material needed for haemostasis
Time frame: during the operation
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 5 Jul 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.
Michel Mourad, MD, PhD principal investigator
St Luc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multinodular Goiter, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 5 Jul 2019. 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 Belgium. 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?
Efficacy, safety and potential advantages of Harmonic Focus for total thyroidectomy (time frame: day one after surgery). 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 5 Jul 2019.