Prospective Pilot Study ANDPrecise

NCT02292407 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2014-11-17

No results posted yet for this study

Summary

This study aims at providing first evidence that axillary clearance by using an operation technique including the precise LigaSure instrument and closure of dead space of the axilla will result in an operation were a drain is not necessary and the need for seroma evacuation after surgery is very limited.

Conditions

Interventions

DEVICE

LigaSure Precise instrument

LigaSure Precise instrument is used during Axillary Lymph Node Dissection Technique: Dead space closure Technique: Omission of postoperative drain

Sponsors & Collaborators

  • The Netherlands Cancer Institute

    lead OTHER

Principal Investigators

  • Emiel Rutgers, MD, PhD · Netherlands Cancer Institute - Antoni van Leeuwenhoek

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2017-06-30
Completion
2018-06-30

Countries

  • Netherlands

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02292407 on ClinicalTrials.gov