NCT00784407

Brief Summary

The objective of this study is to compare the results of total thyroidectomy using the new harmonic scalpel device (FOCUS) to that with the previously available harmonic scalpel device (HARMONIC ACE).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2008

Shorter than P25 for not_applicable

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

February 1, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 3, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 2008

Completed
Last Updated

November 4, 2008

Status Verified

October 1, 2008

Enrollment Period

5 months

First QC Date

November 3, 2008

Last Update Submit

November 3, 2008

Conditions

Thyroidectomy

Keywords

thyroid surgerytotal thyroidectomyharmonic scalpel

Outcome Measures

Primary Outcomes (3)

  • Hemostasis

    intraoperatively & postoperatively

  • Postoperative complications including laryngeal nerve palsy, hypocalcemia, hemorrhage, hematoma, wound infection and skin burn

    postoperatively

  • Operative time

    from skin incision to skin closure

Secondary Outcomes (1)

  • Length of hospital stay

    postoperatively

Study Arms (2)

FOCUS (group A)

ACTIVE COMPARATOR

Patients submitted to total thyroidectomy with the use of the FOCUS harmonic scalpel device

Device: harmonic scalpel device utilized intraoperatively

HARMONIC ACE (group B)

ACTIVE COMPARATOR

Patients submitted to total thyroidectomy with the use of the HARMONIC ACE harmonic scalpel device

Device: harmonic scalpel device utilized intraoperatively

Interventions

harmonic scalpel device utilized intraoperativelyDEVICE

harmonic scalpel device utilized intraoperatively (FOCUS in group A and HARMONIC ACE in group B patients)

FOCUS (group A)HARMONIC ACE (group B)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • total thyroidectomy

You may not qualify if:

  • hemithyroidectomy
  • additional surgical procedures together with the total thyroidectomy (i.e. parathyroidectomy or cervical lymph node dissection)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrine Surgery, 1st Department of Propaedeutic Surgery, Hippocratio General Hospital of Athens, Athens Medical School, University of Athens

Athens, Abelokipoi (Q. Sofias 114 Av.), 11527, Greece

Location

Study Officials

  • Andreas Manouras, PhD

    Department of Endocrine Surgery, 1st Department of Propaedeutic Surgery, Hippocratio General Hospital of Athens, Athens Medical School, University of Athens, Athens, Greece

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 3, 2008

First Posted

November 4, 2008

Study Start

February 1, 2008

Primary Completion

July 1, 2008

Study Completion

October 1, 2008

Last Updated

November 4, 2008

Record last verified: 2008-10

Locations

GR(1)