Clinical Feasibility of New Tracheoesophageal Puncture Set

Atos Medical

Status: Completed

Conditions: Larynx Cancer

Treatments: Device: Puncture Set and Flexible Protector

Study type: Interventional

Funder types: Industry

Identifiers

NCT01045057

UD743_FRITZ_MULTI

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• primary puncture during total laryngectomy
• secondary puncture some time after total laryngectomy

Exclusion criteria

• anatomical abnormalities that prevent appropriate pharynx protection during secondary puncture
• not eligible to use a voice prosthesis for other reasons

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Puncture Set and Flexible Protector

Experimental group

Description:

Provox Vega Puncture Set is used to create the primary puncture and insert the prosthesis during total laryngectomy

Treatment:

Device: Puncture Set and Flexible Protector