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CompletedNCT01003652Updated Jul 5, 2019

Clinical Trial on Harmonic Focus Shears

An observational study in Multinodular Goiter, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-05.

Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
68
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Multinodular Goiter

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Keywords

  • goiter
03

In context

Goiter

66 studies on the registry are indexed under Goiter; 11 are open to participants now.

This study's enrollment of 68 is below the median of 104 across 23 observational studies indexed under Goiter.

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Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain is the lead sponsor of 350 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

68 patients candidate to total thyroidectomy for multinodular goiter in an academic hospital

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Total thyroidectomy for multinodular goiter in adults patients

Exclusion criteria

Exclusion Criteria:

  • Redo surgery, .
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
68 participants (actual)

Groups and cohorts

  • 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

Interventions

  • Procedurethyroidectomy

    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

06

What researchers measure

Primary outcomes

  1. Efficacy, safety and potential advantages of Harmonic Focus for total thyroidectomy

    Time frame: day one after surgery

Secondary outcomes

  1. Impact on bleeding, operative time, instrument exchanges, material needed for haemostasis

    Time frame: during the operation

07

Study locations

1 site
  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain
    Brussels, 1200, Belgium
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01003652
Responsible party
Sponsor
First posted
Oct 29, 2009
Start date
Jan 2008
Primary completion
Dec 2008
Completion
Dec 2008
Last update
Jul 5, 2019

Study contacts

Michel Mourad, MD, PhD
principal investigator · St Luc

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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