MDACC Study Summary 2003-0509

Study Summary
No. 2003-0509:.......Head And Neck......Jan S. Lewin......Head/Neck Surgery

Study Summary Title



Study Summary Number:	2003-0509

Study Title:	Modification of the Tracheoesophageal (TE) Voice Prosthesis for the Problem TE Puncture

Physician

New Patient Referral



Name:	Jan S. Lewin	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Head/Neck Surgery	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-2309 Contact us about clinical trials

General Information



Disease Group:	Head And Neck	Supported By:	N/A

Phase of Study:	Phase I	Return Visit:	Minimum of 1-2 visits. Additional visits will be scheduled per patient need.

Treatment Agents:	Custom TE Voice Prosthesis	Home Care:	Patient and/or significant other will perform routine care and cleaning of stoma and TE prosthesis similar to standard management of standard TE prosthesis.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	Hospitalization is not indicated for this study.


Description/ Intervention:	The goal of this clinical research study is to learn if placing an individually designed special TE prosthesis into your TE puncture to plug the hole will prevent fluids and food from getting sucked into your lungs.

Study Objectives / Outcomes

1. To develop a modified TE voice prosthesis to prevent aspiration through the tracheoesophageal (TE) puncture in patients who have had a total laryngectomy and TE puncture.
2. To evaluate patient response and functional outcomes using a modified TE voice prosthesis.

3. To assess the duration of sustained effect using a modified TE voice prosthesis.

4. The primary endpoint is to document decreased aspiration through the TE puncture using a modified TE prosthesis based on history and physical examination.

Study Status Information



Study Activation / Registration Date:	09/25/2003

IRB Review and Approval Date:	07/07/2003

Study Type:

Recruitment Status:	Closed

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patients with a tracheoesophageal puncture who are being seen in the Department of Head and Neck Surgery for leakage through the TE puncture.

2) Patients with a tracheoesophageal puncture who are referred directly to the Section of Speech Pathology for leakage through the TE puncture.

3) Patients who have signed an informed consent and authorization, indicating awareness of the risks associated with the placement of an investigational customized TE prosthesis.

Exclusion Criteria:

1) None

Links

Registration Number: Not Registered