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Research Study Management
We manage research studies for independent investigators and small and medium sized companies in Israel and abroad. Our center collaborates with well known local and international physicians researchers and institutions such as the Israel Heart Society, the Israel Neurological Society and the Israel Ministry of Health.
Research study services include:
- Preparation of protocols
- Building and printing of electronic CRF
- Support for Helsinki submission
- Follow up monitoring and preparation for audit
- Follow up monitoring of unscheduled events
Sample Projects
CRT Upgrade
A clinical research study in collaboration with Semmelweiss University Budapest. The study includes centers in Europe and Israel and is aimed at investigating the effect of upgraded ICD device to CRTD vs standard ICD device
The enrollees are signed on informed consent and then randomized for upgrading their ICD to CRTD device versus those who remain with the standard ICD device.
Over 300 patients have been enrolled in 20 medical centers. End of study is estimated for end of 2020.
Research Page
BrainQ
A Clinical interventional study at the Sheba Medical Center as well as at two medical centers in the USA.
The study's objective is to investigate the safety and efficacy of a therapeutic device developed for treating neurological damage. The study is designed for patients with chronic spinal damage to the upper body limbs after undergoing physiotherapy for a month with no definite improvement compared to their condition at the start of treatment.
The patients were enrolled from patients previously hospitalized in the neurology rehabilitation department and also from the general population who were referred for treament.
The study questionnaire collects data on the patients' functioning prior to treatment, during and after treatment. Following detailed analysis, conclusions will be reached regarding effective safe therapy.
Research Page
CardiCare
Non-interventional neuromodulation for reducing prior conditions of atrial fibrillation after conversion to sinus rhythm
A future clinical study at the Sheba Medical Center involving the testing of a device CardiacCare RR2 which is a personal bracelet worn by patients that monitors via ECG and neuromodulation.
A non interventional treatment that should reduce prior atrial fibrillation following conversion.
This new device in its primary stage will be checked for its technical and technological viability in the patient's home and will undergo technological programming and implementation. The study questionnaire will collect details on the patients medical condition before the trial, during and at the end of the trial, thereby testing its ability for easy use and effective treatment.
Research Page
Celiac Plexus
Radiosurgery to celiac plexus for treatment of pain in cancer patients
a second phase study
An international multicenter interventional clinical trial in phase 2. The aim is to investigate the safety and efficacy of focused radiation therapy to the celiac plexus area to reduce level of pain in patients suffering from cancer in that region (abdominal).
A preliminary study performed at Tel Hashomer showed significantly reduced pain in patients who had undergone this treatment and improved state of mind and quality of life and survival.
To date 50 patients have been enrolled in 3 centers in Israel (Sheba, Ichilov and Assuta) and 4 additional centers in Canada, Ohio, Mount Sinai NY and Portugal.
Research Page