Prospective, randomized clinical trial for the comparison of the voice protheses Phonax® and Provox II® - Phonax

Klinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde Leipzig0 个研究点目标入组 22 人开始时间: 2014年5月21日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•histologically verified, primary resectable Larynx/Hypopharynxcarcinoma
•indikation for laryngectomy with primary creation of a tracheo esophageal fistula
•planned curative resection (R0-resection)
•stage II/IV A ollowing UICC (without T1)
•low to slightly enhanced risk of anesthesia
•adequate bone marrow-, liver- and kindneyfunction
•Karnofsky-Index =70%
•Age 18-80 Years
•written informed consent

•tumorspezifc pre-treatment (chemotherapy, radiation therapy)
•Metachrone or synchrone malignom (exception: basaliom or low-risk prostatecarcinoma) [In case of a controlled tumor at a different location with a treatment free intervall of more than 5 years, inclusion might be possible after consultation of the co-ordinating investigator]
•life expectancy < 6 months
•acute infection or fever
•anamnestic HIV-infection or othe immune suppression
•serious cardio-pulmonary concomittant disease (heart insufficiency grade III and IV following NYHA scale, myocardial infarction, angina pectoris, respiratoric insufficiency serious Asthma bronchiale, COPD (FEV1 <35%))
•chronic disease with permanent therapy (uncontrolled Diabetes, rheumatoide Arthritis) particularly steroid therapy
•other concomittant diseases, which exclude the patient from the trial from the perspective of the trial physician
•analphabetism
•intolerance regarding the materials of the voice protheses
•experienced low patient's compliance
•regular follow-up impossible (e. g. patient lives outside of Germany)
•lack of or patial legal capcity of the patient
•participation in another clinical trial or application of a not yet registered substancewithin 30 days before trial start
•pregnant or nursing
•fertile female patients (< 2 years after the last spontaneous menstruation) without effective contraception (implants, injections, oral contraceptives, intrauterine devices, vasectomized partner)

发起方

Klinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde Leipzig