Clinical Trials at Cottage
Partners for Medical Advancements – Clinical Research Coordinators
Cottage Health is an active participant in industry-funded clinical trials that lead to the prevention, detection and treatment of diseases with new or improved medical advances in health care. Cottage has participated in more than 200 clinical trials ranging from phase 2 to phase 4 studies with more than 500 enrollments across all studies.
A dedicated team of Clinical Research Coordinators is available to manage day-to-day activities, which include patient recruitment, consent, screening, data entry, regulatory, Institutional Review Board (IRB) submissions, and monitoring visits.
According to the National Institutes of Health (NIH), “Clinical trials are part of clinical research and at the heart of all medical advances. Clinical trials look at new ways to prevent, detect, or treat disease. Clinical trials can study:
- New drugs or new combinations of drugs
- New ways of doing surgery
- New medical devices
- New ways to use existing treatments
- New ways to change behaviors to improve health
- New ways to improve the quality of life for people with acute or chronic illnesses
The goal of clinical trials is to determine if these treatment, prevention, and behavior approaches are safe and effective.”
Source: https://www.nih.gov/health-information/nih-clinical-research-trials-you/basics. Accessed 23 October 2024.
To obtain more information on active studies:
Clinical Trials Available at Cottage
EMBLOK Study
Title: A Prospective, Randomized, Multicenter Evaluation of the Safety and Effectiveness of the EMBLOK™ Embolic Protection System during Transcatheter Aortic Valve Replacement
Description: The primary objective of this study is to evaluate the safety, effectiveness, and performance of the EMBLOK™ Embolic Protection System (EMBLOK EPS) during transcatheter aortic valve replacement (TAVR) by randomized comparison with a commercially available embolic protection device. Eligible patients will either receive the EMBLOK EPS during TAVR or be randomized to one of the two treatment arms: EMBLOK EPS during TAVR or commercially available embolic protection device during TAVR. Patients whose anatomy is not suited for use of the commercially eligible device may qualify for enrollment in a nested registry. Participants will undergo clinical follow-up in hospital and at 30 days.
Primary Investigator: Dr. Michael Shenoda, MD, FACC, FSCAI
Contact: CHRI@sbch.org or 805-287-6260
https://clinicaltrials.gov/study/NCT05295628
GORE GSO 18-01 Study
Title: GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients with Patent Foramen Ovale (PFO): the REDUCE Post Approval Study (REDUCE PAS)
Description: The GORE GSO 18-01 study is a Post Approval Study assessing the safety and effectiveness of the GORE Septal Occluder device as observed in the REDUCE pivotal IDE study and evaluating the quality of operator education and training and transferability of trial experience to a post-market setting. The full study title is “GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients with Patent Foramen Ovale (PFO): the REDUCE Post Approval Study
Primary Investigator: Dr. Joseph Aragon, MD, FACC, FSCAI
Contact: CHRI@sbch.org or 805-287-6260
https://clinicaltrials.gov/study/NCT03821129
ALLAY-HF Study
Title: ALLAY-HF STUDY - Safety and Efficacy of the Alleviant System for No-Implant Interatrial Shunt Creation in Patients with Chronic Heart Failure
Description: This is a prospective, multicenter, randomized, sham-controlled, double blinded, adaptive study designed to evaluate the safety and efficacy of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with chronic heart failure (HF) and preserved ejection fraction (HFpEF) or mildly reduced ejection fraction (HFmrEF), who remain symptomatic despite appropriate guideline directed medical therapy (GDMT). Patients will be randomized in a 1:1 ratio to undergo the investigational device procedure or a sham-control procedure. Primary analysis will be conducted after all subjects complete 12 months of follow-up. Regular follow-up visits are planned to occur through 5 years after the index procedure for all study subjects. Sham-control subjects will be offered an opportunity to cross-over after the 24-month follow-up and undergo the investigational device procedure if they meet study eligibility criteria at that time.
Primary Investigator: Drs. Joseph Aragon, MD, FACC, FSCAI and Michael Shenoda, MD, FACC, FSCAI
Contact: CHRI@sbch.org or 805-287-6260
https://clinicaltrials.gov/study/NCT05685303
NAIL-IT Study
Title: EVALUATION OF THE SAFETY AND THROMBOLYTIC EFFECTS OF
ASCENDING DOSES OF TS23 (DS-9231) IN SUBJECTS WITH INTERMEDIATE-RISK (SUB-MASSIVE) ACUTE PULMONARY EMBOLISM
Description: This Phase 2 study aims to assess the pharmacokinetics, pharmacodynamics, safety, and thrombolytic effects of ascending IV doses (3, 5, and 7 mg/kg versus placebo) of TS23 in subjects with intermediate-risk acute pulmonary embolism (PE). Participation will last about 1 month.
Primary Investigator: Dr. Natalie Achamallah
Contact: CHRI@sbch.org or 805-287-6260
https://clinicaltrials.gov/study/NCT05408546
Fetal Microchimerism
Title: Immune Regulation, Microchimerism and Maternal-Infant Health
Description: This study is a collaboration with SBCH and UCSB that aims to understand how the pregnant person's immune system responds to fetal cells circulating throughout pregnancy. The study involves three blood draws and two short surveys. Additionally, participants have the option to include family members, who may consent to provide saliva samples for further research.
Primary Investigator: Amy Boddy, PhD
Contact: CHRI@sbch.org or 805-287-6260
https://momshealth.anth.ucsb.edu/home
Clinical Trials – Research Participants
What is clinical research and why is it done?
Clinical research is medical research that studies people to understand health and disease. Clinical research helps improve the way doctors treat and prevent illness. Through clinical research, researchers learn:
- How the body works
- How illness develops in people, such as how diseases get better or worse over time
- How the body handles a possible treatment (including medicines or devices)
- Which behaviors help people stay healthy and prevent illness, and which behaviors raise the chance of illness
The goal is to use science to improve people’s healthcare and health over time. The participants who join and take part in clinical research studies may or may not get any benefit for themselves.
Who can join clinical research?
Researchers look for people who fit a certain description, called eligibility criteria. These criteria give details on who can and cannot join a study and could include:
- People of a certain age or gender
- People who do or do not have a certain illness, disease, or health condition
- People with or without a certain health history, such as a prior treatment
- People who are exposed to or are in contact with something that affects their health
Researchers use eligibility criteria to keep participants safe and enroll the right participants to collect the data they need to answer the research question. There are many kinds of research studies, all with different types of eligibility criteria.
Source: www.clinicaltrials.gov/study-basics/learn-about-studies/. Accessed 23 September 2024.
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If you are interested in participating in a research study, there are several ways to find an appropriate one for you:
If you are a Cottage Health patient:
Go to https://mychart.sbch.org/mychart/Authentication/Login , and follow these steps:
- Sign into your Cottage Health MyChart.
- From the home page, scroll to the bottom.
- Under the "Explore More" tab, swipe to the "Research Studies" tile and click "Learn More.“
- Select "OK to Contact" and click "Create Profile.“
- Respond to the series of questions and click "Save."
Send an email to Cottage Health Research Institute, chri@sbch.org.
Log onto ClinicalTrials.gov to find a study, How to Search for Clinical Studies | ClinicalTrials.gov.
Research Participants
More Information
For more information contact research at CHRI@sbch.org
Do you have a question, concern or complaint about your involvement in a research study or your rights as a research participant?
If so, please feel free to contact the IRB confidentially at (805) 287-6260 or CHRI@sbch.org.
State of California Experimental Subject’s Bill of Rights
As a research participant, you have the following rights:
- To be told what the study is trying to find out.
- To be told what will happen to me and whether any of the procedures, drugs or devices is different than what would be used in standard practice.
- To be told about the frequent and/or important risks, side effects, or discomforts associated with the things that will happen to me for research purposes.
- To be told if I can expect any benefit from participating and, if so, what the benefit might be.
- To be told the other choices of procedures, drugs or devices I have and how they may be better or worse than being in the study, including risks and benefits.
- To be allowed to ask any questions concerning the study and procedures both before agreeing to be involved and during the course of the study.
- To be told what sort of medical treatment is available if any complications arise.
- To refuse to participate at all or to change my mind about participating after the study has started. This decision will not affect my right to receive the care I would receive if I were not in the study.
- To receive a copy of the signed and dated consent form.
- To be free of pressure when considering whether I wish to agree to be in the study or not participate.
