Clinical Trials With Medical Devices
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Example of an innovative clinical trial design for a group of medical devices (in this case absorbable hemostats) to support a particular clinically relevant claim
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3) Phase IV trials monitor safety after approval and can find rare side effects.
4) Trials must follow ethics guidelines to protect participants and receive oversight from institutional review boards.
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Here are the key points to cover in your answer:
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Clinical research involves systematic studies on humans to test new drugs, devices, or procedures for safety and effectiveness. The document outlines the various phases of clinical research and drug development process. It describes the roles and responsibilities of key players on a research team including the principal investigator, clinical research coordinator, clinical research associate, and others. It also discusses ethical principles in clinical research and important considerations like informed consent and safety monitoring.
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Clinical trials generate safety and efficacy data for health interventions in human beings and are conducted after satisfactory pre-clinical animal testing. There are various types of clinical trials including observational studies, interventional studies, prevention trials, screening trials, diagnostic trials, and treatment trials. Clinical trials progress through phases including pre-clinical, Phase 1, Phase 2, Phase 3, and Phase 4 post-marketing surveillance trials. The goal is to demonstrate a treatment's safety and efficacy compared to current standard of care.
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Clinical research involves conducting research studies in human volunteers to answer health questions and find new treatments. It typically involves several phases from preclinical testing in animals to clinical trials in human subjects. India is emerging as a global hub for clinical research due to its large patient pools, low costs, and trained professionals. However, there is a large gap between the growing demand for trained clinical research professionals and current supply. Cliniminds aims to address this need by providing a wide range of clinical research training programs and courses.
Clinical Trials Introduction
The document provides an overview of clinical trials, including:
1) Clinical trials involve studying new drugs, procedures, or therapies on human subjects to test safety and efficacy.
2) Trials are organized into phases from 0 to IV, with Phase 0 involving microdosing and Phase I-III testing in larger groups.
3) Phase IV trials monitor safety after approval and can find rare side effects.
4) Trials must follow ethics guidelines to protect participants and receive oversight from institutional review boards.
Clinical trials flow process
This document discusses the clinical trials process from protocol development through study completion. It covers developing the protocol, regulatory documents, patient recruitment, safety reporting, interim reports, and end of study activities. Key aspects include writing an approvable protocol, establishing an investigator site file, screening and enrolling suitable patients, maintaining safety oversight, and conducting closeout procedures. The goal is to provide guidance on managing all stages of a clinical trial.
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Clinical Trial Phases
Clinical trials involve several phases:
- Phase I trials involve small groups of healthy volunteers or patients and aim to determine the safety and tolerability of a new drug.
- Phase II trials involve larger groups of patients and aim to determine efficacy and further evaluate safety. These trials provide preliminary data on effectiveness.
- Phase III trials involve even more patients and aim to confirm effectiveness, monitor side effects, and compare the new treatment to standard treatment. These trials provide the primary data to support effectiveness. Regulatory approval is based on positive Phase III results showing safety and effectiveness.
Monitoring and auditing in clinical trials
Monitoring and auditing are important quality control activities in clinical trials. Monitoring ensures accurate and compliant conduct of trials, while auditing independently evaluates trial conduct and compliance. Key aspects include:
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Introduction:Cutaneous necrosis followed by ulceration and formation of abscess is not a rare complication of foam sclerotherapy. As sclerotherapy reduces the surgery burden and time consuming; it became popular for destroying varicose veins. Sometimes this complication may make the post operative period unpleasant.
Material & Methods:Forty three patients with varicose vein who had undergone surgery at three centers during a period of six months by same surgical team were included in the study.
Intra-lesional injection of sodium tetradecyl sulphate (STS) was used for varicosities during surgery in seventeen patients of flush ligation and eight patients of EVLA (endovenous laser ablation). Foam was applied in another eleven patients of flush ligation and seven patients of EVLA one month after surgery during follow up visit. All patients were followed up for two months.
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With immediate sclerotherapy after flush ligation and stripping of GSV only one patient developed ulcer.
None had ulcer when sclerotherapy practiced after one month of flush ligation with stripping of GSV.
With immediate sclerotherapy following EVLA, three patients developed ulcer.
Sclerotherapy after one month of EVLA one patient was found developed infected ulcer.
In my small study I found infected skin ulceration as a common complication which occurred in both open surgery and EVLA patients. It was more common in EVLA group. It was also common when foam applied along with surgical/ EVLA procedure.
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In open surgery patients, skin ulceration was also common.
In both group of patients, number of skin ulceration was more when foam was applied along with surgical/ EVLA procedure in comparison to those where it was practiced after two months during follow up period.
In my observation, skin ulceration was more common in EVLA patients. Further study is required to find any correlation between laser therapy and sodium tetradecyl sulphate.
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Chest tube management
- Chest tube (CT) placement is often used to treat pneumothorax, hemothorax, or pleural effusion following injury or surgery. However, the optimal management of CTs after placement is variable.
- Studies show CTs can safely be removed when drainage is ≤200ml/day or ≤2ml/kg/day, and that removal at end-inspiration or end-expiration carries similar risk of recurrence. Removal on suction is as safe as a brief trial of water seal.
- For non-ventilated patients, post-removal CXR may not be needed if stable. In ventilated patients, a CXR 1-3 hours post-removal is sufficient to
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Clinical Trials With Medical Devices
- 1. Clinical Trials with Medical Devices: Example of an Exciting and Challenging Field Harrie van Baars, MD November, 2010
- 2. The Claim: Absorbable hemostats are being absorbed by the body in a certain time frame to prevent adhesion formation and encapsulation, ideally with a maximum of 4-6 weeks;
- 3. The Challenge: How to support the claim that Absorbable Hemostats are really being absorbed in a given time frame when implanted in humans
- 4. The Problem: Patients can not be re-operated to proof efficacy of a surgical procedure, unless certain complications require re-surgery
- 5. The Solution: There are certain diagnostic surgical procedures that are invasive, needing the use of hemostats, and may lead to re-surgery within a given time frame;
- 6. The Execution: VAMLA: Video Assisted Mediastinoscopic Lymphadenectomy; In this procedure lymph nodes are being removed from the mediastinum with the help of video assistance to perform staging in lung cancer patients; The staging will then define whether patients need to undergo lung resection or palliative care; the removal of lymph nodes may cause bleeding for which hemostats can be used; In case of resection this usually takes place between 5-25 days after the VAMLA procedure; These patients will be eligible for the trial
- 7. Trial Center and Clinical Investigator: Martin Hürtgen, MD. Department of Thoracic Surgery, Katholisches Klinikum Koblenz, Koblenz, Germany
- 8. Mediastinoscopy (VAMLA) Lymphnode + Lymph node - Thorax surgery Within 5-25 days Non- invasivetherapy Thorax surgery Within 2-3 mths None or Palliative treatment No rest HemostatRest Hemostat None or palliative treatment The Clinical Trial Design: Observation à vue and PA
- 9. Days 2 4 6 8 10 12 14 16 18 20 22 24 26 28 The Results:ML 10 8 6 4 2 0 Liquid Solid
- 10. The Trial Summary: The application of significant amounts of oxidised cellulose in the mediastinum is safe and effective. Gauze measuring 5x20 cm quickly dissolves and is completely absorbed within 14 days. The impression of reduced seroma formation, absence of post-surgical local inflammation and adhesion formation is interesting and suggests a comparative randomised follow up study
- 11. The Publication: “OXIDISED CELLULOSE IN THORACIC SURGERY – HUMAN IN VIVO STUDY OF EFFICACY, SAFETY AND ABSORPTION PROPERTIES” 17th European Conference on Thoracic Surgery, June 2009, Krakow, Poland
- 12. The Conclusion: Clinical trials with Medical Devices pose interesting challenges in comparison with pharmaceutical compounds. Nevertheless, with innovative approach and out of the box thinking excellent results can be obtained.