Clinical Feasibility of New Tracheoesophageal Puncture Set

NCT01045057 | Completed Results

• 1 other identifier: UD743_FRITZ_MULTI
• Study Type: interventional
• Target: 27
• Locations: 4 countries
• Sites: 5

Brief 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

Keywords

voice prosthesis, larynx cancer, laryngectomy

Outcome Measures

Primary Outcomes (1)

• Success Rate of Procedure

  As successful counted all successful procedures in which the tracheal flange of the voice prosthesis unfolded completely without help of additional tools. A success rate of 80% and higher was considered acceptable.

  immediate observation during surgery

Secondary Outcomes (3)

• Satisfaction of Physician

  1 month

• Cost Effectiveness Calculation

  1 month

• Postoperative Results

  1 month

Study Arms (1)

Puncture Set and Flexible Protector

EXPERIMENTAL

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

Device: Puncture Set and Flexible Protector

Interventions

Puncture Set and Flexible Protector DEVICE

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.

Puncture Set and Flexible Protector

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Atos Medical AB: lead

Study Sites (5)

University Hospital Leuven

Leuven, 3000, Belgium

Location

Bundeswehr Krankenhaus

Ulm, 89081, Germany

Location

Netherlands Cancer Institute

Amsterdam, North Holland, 1066 CX, Netherlands

Location

Erasmus Medical Center

Rotterdam, South Holland, 3015GD, Netherlands

Location

Hospital de la Santa Creu I Sant Pau Universitat Autònoma de Barcelona

Barcelona, 08025, Spain

Location

MeSH Terms

Conditions

Laryngeal Neoplasms

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Director of Clinical Affairs
• Organization: Atos Medical AB

Corina.van.As@atosmedical.com

+1 352 870 0872

Study Officials

• Frans JM Hilgers, MD, PhD

  The Netherlands Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Provox Vega Puncture Set

Study Record Dates

• First Submitted: January 6, 2010
• First Posted: January 8, 2010
• Study Start: December 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: April 1, 2011
• Last Updated: June 11, 2021
• Results First Posted: February 10, 2015

Record last verified: 2021-06

Locations

NL (2); ES (1); DE (1); BE (1)