NCT01003652

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 29, 2009

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

11 months

First QC Date

October 27, 2009

Last Update Submit

July 1, 2019

Conditions

Multinodular Goiter

Keywords

goiter

Outcome Measures

Primary Outcomes (1)

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

    day one after surgery

Secondary Outcomes (1)

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

    during the operation

Study Arms (4)

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

thyroidectomyPROCEDURE

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

Harmonic Focus /conventional haemostasis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Total thyroidectomy for multinodular goiter in adults patients

You may not qualify if:

  • Redo surgery, malignancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Goiter

Interventions

Thyroidectomy

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Endocrine Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Michel Mourad, MD, PhD

    St Luc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2009

First Posted

October 29, 2009

Study Start

January 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

July 5, 2019

Record last verified: 2019-07

Locations

BE(1)