Clinical trials: sponsored by IRCCS San Raffaele
Prostate Cancer
Longitudinal Evaluation of Intestinal, Haematological and Urinary Toxicity From Pelvic Irradiation for Prostate Cancer
The prophylactic irradiation of pelvic lymph-nodes by means of Whole-Pelvis Radiotherapy (WPRT) in the treatment of prostate cancer (PCa) is aimed at the timely eradication of microscopic lymph-nodal metastases.
- Trial name
- IHU-WPRT-TOX (NCT02803086)
- Where
- Italy
- Volunteers
- 700 people
- Sponsor
- IRCCS San Raffaele
High Grade Glioma, High Grade Meningioma
Liquid Biopsy in High-grade Gliomas and Meningiomas
The general objective of this project is to evaluate the value of cell-free DNA circulating in plasma as a marker of tumor evolution in patients with high-grade gliomas and meningiomas.
- Trial name
- SOPRANO (NCT05630664)
- Where
- 5 sites in Italy
- Volunteers
- 90 people
- Sponsor
- IRCCS San Raffaele
Beta Thalassaemia
Long-term Follow-up of Subjects Treated With OTL-300 for Transfusion Dependent Beta-thalassemia Study (TIGET-BTHAL)
OTL-300 is a gene therapy drug product consisting of autologous hematopoietic stem/progenitor cluster of differentiation (CD) 34+ cells genetically modified with a lentiviral vector (GLOBE) encoding the human beta globin gene.
- Trial name
- NCT03275051
- Testing
- Safety and Efficacy assessments
- Where
- Italy
- Volunteers
- 9 people
- Sponsor
- IRCCS San Raffaele
Thoracoabdominal Aortic Aneurysms
A PROpensity Score Matching Analysis on ENDovascular vs Open Thoraco-Abdominal Aortic Aneurysm Repair (PRO-ENDO TAAA Study)
The purpose of the registry is to compare the surgical and endovascular approaches to the treatment of thoracoabdominal aortic aneurysms.
- Trial name
- PRO-ENDO TAAA (NCT05266781)
- Testing
- Surgical repair, Endovascular repair
- Where
- Italy
- Volunteers
- 650 people
- Sponsor
- IRCCS San Raffaele
Aneurysm Abdominal, Aneurysm Thoracic
MuLtibranchEd Graft for OPen RepAir of ThoRacoabdominal Aneurysms
The objective of the study is the evaluation of the technical success and clinical outcomes of the surgical treatment of thoraco-abdominal aortic aneurysms treated by Jotec "TAAA spinal loop graft" "custom made "CE equivalent"…
- Trial name
- NCT04430114
- Testing
- branched prosthesis for surgical treatment of thoraco-abdominal aortic aneurysms
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- IRCCS San Raffaele
Aneurysms Aortic Arch
Evaluation of Supra-aortic Trunks Debranching Techniques in Open Arch Repair by Means of Frozen Elephant Trunk Procedure With Two Configurations of the Jotec E-Vita Hybrid Graft (FETOPT)
To evaluate two different supra-aortic trunks debranching techniques during open repair of aortic arch aneurysms by means of Frozen Elephant Trunk procedure with two configurations of the Jotec E-Vita hybrid graft.
- Trial name
- FETOPT (NCT03600077)
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- IRCCS San Raffaele
Aneurysm
COvera in BRAnch Registry
The purpose of the registry is to evaluate the peri-operative and short-, mid- and long-term outcomes of the Bard Covera Plus (Tempe, Arizona, USA) for the treatment of atherosclerotic aorto-iliac aneurysm in combination with a…
- Trial name
- NCT04598802
- Testing
- covered stent
- Where
- 33 sites in Germany, Italy
- Volunteers
- 300 people
- Sponsor
- IRCCS San Raffaele
Subclavian Artery Plug Embolization
Subclavian Artery Plug Embolization (SAPE)
This is an observational, no-profit, ambispective study: a retrospective arm will include the cases treated between August 2009 and March 2018, and a prospective arm, investigating patients treated from March 2018 until December…
- Trial name
- SAPE (NCT03620006)
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- IRCCS San Raffaele
Surgical and the Percutaneous Approach to the Upper Extremity Access
SUrgical Versus PERcutaneous AXillary Artery International Registry
The purpose of the Study is to compare the outcomes of the surgical and the percutaneous approach to the upper extremity access (axillary or brachial artery) during endovascular procedures on the aortic valve, the aorta, and its…
- Trial name
- NCT04589962
- Testing
- access axillary or brachial artery
- Where
- 18 sites in United States, Austria and 8 more
- Volunteers
- 700 people
- Sponsor
- IRCCS San Raffaele
Thoracoabdominal Aneurysm
Evaluation of STaged Endovascular Aneurysm Repair in the Management of Thoracoabdominal Pathology by Means of Branched and Fenestrated Devices.(STEAR)
The study aims to analyzing the impact of the staged endovascular treatment (divided into two or more distinct procedures) of thoracoabdominal aneurysmatic pathology on short and medium term, technical and clinical outcomes and…
- Trial name
- STEAR (NCT03342755)
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- IRCCS San Raffaele
Aortic Aneurysm, Abdominal, Aortic Aneurysm, Thoracic
TOtal tRansfemoral branCHed endovasCular tHoracoabdominal Aortic Repair Registry
The purpose of the registry is to evaluate the peri-operative, short-, and mid- outcomes of endovascular treatment of thoracoabdominal aneurysms with multibranched endografts via total transfemoral approach for visceral vessels…
- Trial name
- NCT04930172
- Testing
- Steerable introducers
- Where
- 7 sites in Italy
- Volunteers
- 100 people
- Sponsor
- IRCCS San Raffaele
Aneurysm Abdominal
Anatomical and Perioperative Predisposing Factor for Limb Occlusion of Incraft Infrarenal Endograft (LIMIT Study)
The aim was to determine, within the patient enrolled in three controlled prospective studies, INNOVATION, INSPIRATION and INSIGHT (Sponsor: Cordis, A Cardinal Health Company) studies which are preoperative and postoperative…
- Trial name
- NCT05324657
- Where
- Italy
- Volunteers
- 400 people
- Sponsor
- IRCCS San Raffaele
Stroke
Robot-aided Therapy in Stroke Patients for Upper Limb Rehabilitation
Numerous studies showed that ascertaining the effectiveness of rehabilitative interventions on conditions leading to long-term disability, such as stroke, is a complex task because the outcome depends on many interacting factors.
- Trial name
- MITEEG (NCT01658111)
- Testing
- Robot Group, Traditional physiotherapy
- Where
- 2 sites in Italy
- Volunteers
- 50 people
- Sponsor
- IRCCS San Raffaele Roma
Spinal Cord Injury
Safety Study of Outdoor and Indoor Mobility in People With Spinal Cord Injury (ROBOtics Spinal Cord Injury EKSO).
The aim of this study will be to evaluate the safety and the efficacy of a new robotic exoskeleton device in subjects with Spinal Cord Injury (SCI) and in subjects with other neurological disease with an impairment of lower limbs.
- Trial name
- ROBOSCIEKSO (NCT02065830)
- Testing
- EKSO
- Where
- 2 sites in Italy
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- IRCCS San Raffaele Roma
Vaginal Atrophy, Breast Cancer Female
Histological Modifications of Postmenopausal Vaginal Mucosa After Repeated Carbon Dioxide (CO2) Laser Treatment
To assess the long-term histological and clinical efficacy of MonaLisa Touch procedure for the management of the Genitourinary Syndrome of Menopause (GSM) in postmenopausal female patients.
- Conditions
- Vaginal Atrophy, Breast Cancer Female, Dyspareunia
- Trial name
- REPLAMOD (NCT04868812)
- Testing
- SmartXide 2 V 2 LR, MonaLisa Touch, DEKA, Florence, Italy
- Where
- Italy
- Volunteers
- 15 people
- Sponsor
- IRCCS San Raffaele
Chronic Stroke
Neuroimaging Biomarkers Toward a Personalized Upper Limb Action Observation Treatment in Chronic Stroke Patients
Much recent interest was raised by the use of Action Observation Treatment (AOT) in stroke patients rehabilitation. AOT, well-grounded in neurophysiology, is an updated approach, based on mirror neuron system (MNS) used to…
- Trial name
- BE-TOP (NCT04047134)
- Testing
- Action Observation Treatrment, Observation of videos with Non Motor contents
- Where
- 2 sites in Italy
- Volunteers
- 80 people
- Sponsor
- IRCCS San Raffaele
Patients With COVID-19 Pneumonia Will Allow to Detect an Absolute Reduction in the Rate of Respiratory-failure
Defibrotide in COVID-19 Pneumonia
Phase II, prospective, interventional, single-arm, multicentric, open label trial, with a parallel retrospective collection of data on not treated patients from IRCCS, San Raffaele Scientific Institute included in the…
- Trial name
- DEFI-VID19 (NCT04335201)
- Testing
- Defibrotide Injection
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- IRCCS San Raffaele
Crohn Disease, IBD
Comparing Manual Versus Stapled Side to Side Ileocolic Anastomosis in Crohn's Disease
RESEARCH QUESTION Are handsewn (end to end and Kono S side to side) anastomoses superior to side to side stapled anastomosis after ileocolic resection for Crohn's disease with respect to endoscopic recurrence, gastrointestinal…
- Conditions
- Crohn Disease, IBD, Ileocolitis, Crohn's Ileocolitis
- Trial name
- HAND2END (NCT05246917)
- Testing
- Handsewn anastomosis
- Where
- Italy
- Volunteers
- 189 people
- Sponsor
- IRCCS San Raffaele
Muscle-Invasive Bladder Carcinoma
An Open Label, Single-arm, Phase 2 Study of Neoadjuvant Nivolumab and Nab-paclitaxel Before Radical Cystectomy for Patients With Muscle-invasive Bladder Cancer (NURE-Combo)
To assess whether nivolumab+nab-paclitaxel combination results in patients with muscle-invasive bladder cancer
- Trial name
- NURE-Combo (NCT04876313)
- Testing
- Nivolumab + Nab-paclitaxel, Nivolumab
- Where
- Italy
- Volunteers
- 29 people
- Sponsor
- IRCCS San Raffaele
COVID-19, COVID-19 Respiratory Infection
AI Evaluation of COVID-19 Sounds (AI-EChOS)
In this study the investigators record sounds of voice, breaths and cough of subjects who tested positive for COVID19. The investigators then feed these sounds into an artificial intelligence and see if it can learn to recognise…
- Conditions
- COVID-19, COVID-19 Respiratory Infection, Cough, Breathing Sound
- Trial name
- AI-EChOS (NCT05115097)
- Where
- Italy
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- IRCCS San Raffaele