Philips Magnetic Resonance Study Protocol — Human Volunteer Scanning for System Feasibility, Optimization, Demonstration and Education
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- There is no formal endpoint, as the study is not being conducted to test for safety and efficacy.
研究概览
简要总结
This study is being conducted to generate data for product feasibility and development, product verification and validation, research and development, marketing purposes, image optimization, troubleshooting and demonstration of Philips MR devices, including the education of personnel.All scanning under this protocol is non-diagnostic and done on Philips controlled / owned (test) equipment and locations.
The data is used for optimize, verify and validate technical performance. The studies will not generate any data that can validate clinical/diagnostic -performance or -claims.
There is no formal endpoint, as the study is not being conducted to test for safety and efficacy. However this study protocol will be revised every 3 years.
This is prospective, non-randomized, clinical study evaluating MR with volunteers who provide written informed consent. Eligible volunteers participate in sessions within the MR environment which may include scanning using an investigational or regulatory cleared MR system by a Qualified MR operator. A session may also involve use of regulatory MR accessories with or without scanning. No follow up is conducted after a session.
Population: Up to 300 Healthy volunteers per year.
Study Centers:
All the Volunteers will be screened at Prima Diagnostic center by Co Investigator Dr Dinesh. S and MRI Imaging will be carried out at Philips India Limited by PI Mr Zainudeen Kallumpurath.
| Details of Amended Protocol version No. 2.0 |
|Study Duration
Inclusion Criteria
Additional Site
Informed Consent Document
Summary of Changes
|ü In the previous version No. 1.1, it was mentioned as - It is recommended that the number of visits is limited to a maximum of 12 per year and with a minimum of 4 weeks gap between visits.
ü In the current version No. 2.0, this section is updated as - The interval between visits should be at least 2 weeks.
ü In the previous version No. 1.1, it was mentioned as – Volunteer has passed a general medical health check which involves laboratory investigations like CBC, ESR, RBS, Serum Creatinine, HIV, HbsAg, HCV, Urine analysis, ECG and UPT (for child bearing potential female subjects only.)
ü In the current version No. 2.0, this section is updated as- Volunteer has passed a general medical health check.
ü Additional Site details: Philips GBS LLP
Plot No. B 78 – 79, Chakan Phase-2, MIDC Industrial Area, Maharashtra, India
ü Site specific Informed Consent Document added in amended protocol version no. 2.0, dated 28 Jul 2023.
ü Summary of changes for protocol version no. 2.0, dated 28 Jul 2023 is updated.
ü Also, received approval for the same form the Ethics Committee and uploaded in the CTRI portal.
| Details of Amended Protocol version No. 2.1 |
|Administrative Change
Change of Principal Investigator
Informed Consent Document
Summary of Changes
|ü In the previous version No. 2.0, it was reed as
-Philips India Ltd
Philips Innovation Campus, MFAR Manyata Tech Park, Nagawara, Bangalore-560045, India
ü In the current version No. 2.1, in this it is added as –
-Philips Innovation Campus,Embassy Business hub, Khata No.1368/25/2/25/3, Venkatala Village, Bangalore North Taluk, Bangalore -560064ü In the previous version No. 2.0, it was read as –
Principal Investigator Signature was signed by Mr. Zainudeen Kallumpurath
ü In the current version No. 2.1, in this it is added as –
Principal Investigator Signature is signed by Ms. Alagammai Ramanathan
ü Amended protocol Site Specific Informed Consent Document version no. 2.1, dated 01 Feb 2024 is updated.
ü Summary of changes for protocol version no. 2.1, dated 15 Feb 2024 is updated.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Volunteeris willing and capable of providing informed consent and physically capable of performing study related activities.
- •Volunteer age between 18 -65 years old including either sex.
- •Volunteer has passed a general medical health check which involves laboratory investigations like CBC, ESR,RBS, Serum Creatinine, HIV, HbsAg, HCV, Urine analysis, ECG and UPT( for child bearing potential female subjects only).
排除标准
- •Volunteers with any known contraindications for MR scanning 2) Volunteers with Pacemakers or other implanted electronic devices which are Non MR Compatible 3) Volunteers with metal implants which are not MR conditional or MR safe 4) Volunteers with small metal components in the body (vascular clips, metal splinters, stents, etc.) which are not MR conditional or MR safe 5) Volunteers with epilepsy 6) Volunteer with known severe cardiac disorders, Cerebrovascular, Respiratory, Hepatic, Renal, or Congenital anomaly or any other conditions as per the Physician opinion 7) Volunteers with uncontrolled hyper tension and diabetic Mellitus 8) Volunteers with dermal medicinal patches 9) Volunteers with mental illness or diseases, known claustrophobia, anxiety or panic disorders 10) Volunteers with Meniere’s disease or any previous history of tinnitis 11) Pregnant women 12) Volunteers with significant chronic illness.
结局指标
主要结局
There is no formal endpoint, as the study is not being conducted to test for safety and efficacy.
时间窗: There is no formal endpoint, as the study is not being conducted to test for safety and efficacy.
次要结局
- There is no formal endpoint, as the study is not being conducted to test for safety and efficacy.(There is no formal endpoint, as the study is not being conducted to test for safety and efficacy.)