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Clinical Feasibility of New Tracheoesophageal Puncture Set

NCT01045057 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2021-06-11

Study results available
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Summary

During a total laryngectomy a puncture is created in the tracheoesophageal wall and a voice prosthesis is inserted. With this voice prosthesis the patient learns to speak again. During this study a new surgical tool will be investigated that creates the puncture and places the voice prosthesis.

Conditions

  • Larynx Cancer

Interventions

DEVICE

Puncture Set and Flexible Protector

The Provox Vega Puncture Set will be used to create the tracheoesophageal puncture and place the voice prosthesis. In secondary punctures the Provox Flexible Protector may be used for pharynx protection.

Sponsors & Collaborators

  • Atos Medical AB

    lead INDUSTRY

Principal Investigators

  • Frans JM Hilgers, MD, PhD · The Netherlands Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2011-03-31
Completion
2011-04-30

Countries

  • Belgium
  • Germany
  • Netherlands
  • Spain

Study Locations

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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 NCT01045057 on ClinicalTrials.gov