Clinical Feasibility of New Tracheoesophageal Puncture Set

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Feasibility of a New Voice Prosthesis

NCT05079386

Laryngectomy

COMPLETED NA

Establishment of an Artificial Larynx After Total Laryngectomy

NCT01474005

Carcinomatous Disease

UNKNOWN NA

A Novel Modified Tracheo-Esophageal Voice Prosthesis for Total Laryngectomy Patients

NCT03039465

Laryngeal Cancer Hypopharynx Cancer

UNKNOWN NA

Implantation of Porous Titanium Prosthesis in Laryngeal Surgery

NCT00213863

Vocal Cord Paralysis

UNKNOWN PHASE2

Assessment of Laryngopharyngeal Sensation: Cancer Survivor Cohort

NCT06078527

Presbylarynx Aspiration Spasmodic Dysphonia +6 more

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Larynx Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Provox Vega Puncture Set

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Puncture Set and Flexible Protector

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

Group Type EXPERIMENTAL

Puncture Set and Flexible Protector

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No