Topics

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

2017-02-02 09:53:21 | BioPortfolio

Summary

This study is being conducted at Healthcare Global Enterprises Ltd to evaluate the role of a novel Tracheo-Esophageal voice Prosthesis for total laryngectomy +/- partial pharyngectomy patients. 30 patients will be enrolled as an inpatient or outpatient.

Patients who are planned to undergo total laryngectomy +/- pharyngectomy surgery and trachea-esophageal puncture procedure.(for primary TEP insertion) or patients who have undergone total laryngectomy > 6weeks prior and are suitable candidates for secondary TEP insertion would be recruited to the study. Insertion of the TEP will be done in primary setting or secondary setting. Patients, who are undergoing primary TEP insertion, will be evaluated for speech/ voice at an interval of 6 weeks, 12 weeks and 6 months after the procedure. Patients who are undergoing secondary TEP insertion to be evaluated on the same day of the procedure along with evaluation at an interval of 6 weeks, 12 weeks and 6 months. All the patients will be evaluated clinically for a fluid leak (through and around the TEP) on the same days of voice analysis by giving test feeds under supervision.

Description

This study is being conducted at Healthcare Global Enterprises Ltd to evaluate the role of a novel trachea-oesophageal prosthesis for total laryngectomy +/- partial pharyngectomy patients. 30 patients will be enrolled as an inpatient or outpatient.

Patients who are planned to undergo total laryngectomy +/- pharyngectomy surgery and trachea-esophageal puncture procedure.(for primary TEP insertion) or patients who have undergone total laryngectomy > 6weeks prior and are suitable candidates for secondary TEP insertion would be recruited to the study. Insertion of the TEP will be done in primary setting or secondary setting. Patients, who are undergoing primary TEP insertion, will be evaluated for speech/ voice at an interval of 6 weeks, 12 weeks and 6 months after the procedure. Patients who are undergoing secondary TEP insertion to be evaluated on the same day of the procedure along with evaluation at an interval of 6 weeks, 12 weeks and 6 months. All the patients will be evaluated clinically for fluid leak (through and around the TEP) on the same days of voice analysis by giving test feeds under supervision.

Study Design

Conditions

Laryngeal Cancer

Intervention

Modified Trans-Esophageal Prosthesis

Location

HealthCare Global Enterprises Ltd
Bangalore
Karnataka
India
560027

Status

Recruiting

Source

HealthCare Global Enterprise Ltd.

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-02-02T09:53:21-0500

Clinical Trials [2130 Associated Clinical Trials listed on BioPortfolio]

Clinical Pilot Study of New Prosthesis for Trans-femoral Amputated Patients

Patients with a trans-femoral amputation who experienced problems, complications pain due to the ischial weight bearing and discomfort with conventional socket prosthesis will be proposed ...

Modified Laryngeal Handshake Technique

In this study, we compare the conventional laryngeal handshake technique and modified laryngeal handshake technique for locating the cricothyroid membrane in terms of accuracy and speed. T...

Implantation of Porous Titanium Prosthesis in Laryngeal Surgery

This study evaluates a medialization implant to treat vocal cord paralysis, to permit it to adjust the quality of the voice under local or general anesthesia. The aim is to restore phonati...

Do Laryngeal Tissue Changes in Patients Suspected of Having Laryngopharyngeal Reflux Predict Response to Treatment?

The purpose of the study is to determine if tissue changes are predictor of clinical response to therapy. The hypothesis is that the patients who have laryngeal signs and symptoms related...

Study Evaluating the Effectiveness of the Use of Prosthesis With Trans-Obturator Way for the Correction of Anterior Prolapse

The classical surgical treatment of an anterior prolapse is the use of autologous tissue. In front of the high rate of recurrences with this technique, the use of synthetic prosthesis made...

PubMed Articles [18064 Associated PubMed Articles listed on BioPortfolio]

Clinical Predictors of Laryngeal Preservation Rate in Stage III-IV Laryngeal Cancer and Hypopharyngeal Cancer Patients Treated with Organ Preservation.

To determine factors affecting laryngeal preservation rate in laryngeal and hypopharyngeal cancer patientstreated with organ preservation.

Current status of radiotherapy for patients with thoracic esophageal cancer in Japan, based on the Comprehensive Registry of Esophageal Cancer in Japan from 2009 to 2011 by the Japan Esophageal Society.

Although esophagectomy is the standard treatment for resectable esophageal cancer, chemoradiotherapy or radiotherapy alone is also selected for some cases. However, there have been very few detailed s...

A surgical approach to schwannomas originating from the esophageal branch of the recurrent laryngeal nerve: Pictorial essay.

Schwannoma originating from the esophageal branch of the recurrent laryngeal nerve is clinically rare event. The best approach to preoperative pathological diagnosis, surgery, and airway management fo...

RPL34-AS1 functions as tumor suppressive lncRNA in esophageal cancer.

Ribosomal protein L34 antisense RNA 1 (RPL34-AS1) is novel long non-coding RNA, and was found to be down-regulated in colorectal cancer and gastric cancer. The role of RPL34-AS1 was still unknown in e...

Early Esophageal Cancer: A Gastroenterologist's Disease.

Traditionally, early esophageal cancer (i.e., cancer limited to the mucosa or superficial submucosa) was managed surgically; the gastroenterologist's role was primarily to diagnose the tumor. Over the...

Medical and Biotech [MESH] Definitions

Cancers or tumors of the LARYNX or any of its parts: the GLOTTIS; EPIGLOTTIS; LARYNGEAL CARTILAGES; LARYNGEAL MUSCLES; and VOCAL CORDS.

Branches of the vagus (tenth cranial) nerve. The recurrent laryngeal nerves originate more caudally than the superior laryngeal nerves and follow different paths on the right and left sides. They carry efferents to all muscles of the larynx except the cricothyroid and carry sensory and autonomic fibers to the laryngeal, pharyngeal, tracheal, and cardiac regions.

Branches of the VAGUS NERVE. The superior laryngeal nerves originate near the nodose ganglion and separate into external branches, which supply motor fibers to the cricothyroid muscles, and internal branches, which carry sensory fibers. The RECURRENT LARYNGEAL NERVE originates more caudally and carries efferents to all muscles of the larynx except the cricothyroid. The laryngeal nerves and their various branches also carry sensory and autonomic fibers to the laryngeal, pharyngeal, tracheal, and cardiac regions.

Tumors or cancer of the ESOPHAGUS.

A prosthetic appliance for the replacement of areas of the maxilla, mandible, and face, missing as a result of deformity, disease, injury, or surgery. When the prosthesis replaces portions of the mandible only, it is referred to as MANDIBULAR PROSTHESIS.

More From BioPortfolio on "A Novel Modified Tracheo-Esophageal Voice Prosthesis for Total Laryngectomy Patients"

Quick Search

Relevant Topics

Healthcare
Health care (or healthcare) is the diagnosis, treatment, and prevention of disease, illness, injury, and other physical and mental impairments in humans. Health care is delivered by practitioners in medicine, chiropractic, dentistry, nursing, pharmacy, a...

Arthroplasty
Arthroplasty is a surgical procedure to restore the integrity and function of a joint. A joint can be restored by resurfacing the bones. An artificial joint (called a prosthesis) may also be used. Various types of arthritis may affect the joints. Osteo...

Surgical treatments
Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...


Searches Linking to this Trial