An interventional study of Delfi Personalized Tourniquet System in Blood Flow Restriction (BFR) Training Effects, sponsored by Andrews Research & Education Foundation. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-08.
Sponsored by Andrews Research & Education Foundation · Not applicable, Interventional, and Health services research
The purpose of this observational study is to examine how slowing down blood flow to the legs- a practice called blood flow restriction (BFR)- during exercise by applying compression to the legs affects the way stem cells are released into the blood stream. This will be determined by drawing 6 cubic centimeters (ccs) of blood immediately post-exercise after the Delfi Personalized Tourniquet System (PTS) has been removed. 6 ccs of blood will also be taken prior to exercise and at the 20-, 40-, and 60-minute marks after exercise. The main question of this study is:
In this study, participants will undergo the following:
The proposed study is a prospective, quasi-experiment, dual-center (exercise facility and laboratory) study involving 15 healthy, male and female volunteers. A potential subject must clear the screening, consent to the procedures of this study, and complete the medical interview before proceeding with the familiarization session. The familiarization process will include an introduction to the Delfi BFR Tourniquet System (Delfi Medical Innovations Inc., Vancouver, BC) and the exercises (seated leg extension, semi-reclined leg press, seated hamstring curl) that the subject will complete. The weight each subject will use for each exercise will be determined during this time. All familiarization procedures must be completed prior to the scheduling and execution of the first of twelve experimental testing sessions.
The experimental testing sessions will occur twice a week for six weeks (12 sessions) and will involve the BFR training utilizing the Delfi BFR Tourniquet System, as further described in the Experimental Testing Session section of the treatment plan (6.2). At the beginning of the first, the sixth, and the twelfth testing sessions there will be a blood draw requiring 6 cc of blood to be taken prior to exercise. Post-exercise, at each testing session, additional 6cc blood draws will be conducted immediately post exercise (time point 0), as well as 20- , 40- , and 60 minutes after the conclusion of the workout. Following every testing session workout, finger-prick blood samples for lactate testing will be taken. These blood samples are to be taken at Time point 0- (T 0), 10-, 20-, 30-, 40-, 50-, and 60-minutes following exercise. Once the twelfth experimental testing session has been completed, the subjects will have one final session that is to take place no more than five days following the twelfth testing session. This final session will include one final blood draw of 6 cc. Throughout the duration of the study, the blood drawn will be used for obtaining a complete blood count (CBC) and for cellular analysis to quantify peripheral hematopoietic progenitor cell concentration. The blood samples collected from subject's fingers throughout the study will be used for analysis using a portable lactate analyzer. Lactate analysis will allow researchers insight into each subject's exertion level reflected by the amount of lactate found within the samples collected.
Andrews Research & Education Foundation is the lead sponsor of 20 studies on the registry; 2 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 4 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Volunteers who have medical history involving one or more of the following medical conditions:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group consists of all participants in this study. Subjects must be healthy, and gender is not a factor for enrollment.
Device: Delfi Personalized Tourniquet System
Bilateral proximal thigh bands that will be applied and inflated to a pressure of 80% of occlusive pressure as determined by the automated tourniquet before exercise. A standard exercise session would not include any blood occlusion.
Concentration of Blood Lactate
Allows researchers insight into each subject's exertion level reflected by the amount of lactate found within the samples collected.
Time frame: 1 week after enrollment
Concentration of Blood Lactate
Allows researchers insight into each subject's exertion level reflected by the amount of lactate found within the samples collected.
Time frame: 2 weeks after enrollment
Concentration of Blood Lactate
Allows researchers insight into each subject's exertion level reflected by the amount of lactate found within the samples collected.
Time frame: 3 weeks after enrollment
Concentration of Blood Lactate
Allows researchers insight into each subject's exertion level reflected by the amount of lactate found within the samples collected.
Time frame: 4 weeks after enrollment
Concentration of Blood Lactate
Allows researchers insight into each subject's exertion level reflected by the amount of lactate found within the samples collected.
Time frame: 5 weeks after enrollment
Concentration of Blood Lactate
Allows researchers insight into each subject's exertion level reflected by the amount of lactate found within the samples collected.
Time frame: 6 weeks after enrollment
Prevalence of Hematopoietic Stem Cells
Technique completed using special machine that utilizes lasers to separate and quantify various content of cell samples; used in this study to determine complete blood cell count (CBC) and peripheral hematopoietic progenitor cell concentration
Time frame: 1 week after enrollment
Prevalence of Hematopoietic Stem Cells
Technique completed using special machine that utilizes lasers to separate and quantify various content of cell samples; used in this study to determine complete blood cell count (CBC) and peripheral hematopoietic progenitor cell concentration
Time frame: 2 weeks after enrollment
Prevalence of Hematopoietic Stem Cells
Technique completed using special machine that utilizes lasers to separate and quantify various content of cell samples; used in this study to determine complete blood cell count (CBC) and peripheral hematopoietic progenitor cell concentration
Time frame: 3 weeks after enrollment
Prevalence of Hematopoietic Stem Cells
Technique completed using special machine that utilizes lasers to separate and quantify various content of cell samples; used in this study to determine complete blood cell count (CBC) and peripheral hematopoietic progenitor cell concentration
Time frame: 4 weeks after enrollment
Prevalence of Hematopoietic Stem Cells
Technique completed using special machine that utilizes lasers to separate and quantify various content of cell samples; used in this study to determine complete blood cell count (CBC) and peripheral hematopoietic progenitor cell concentration
Time frame: 5 weeks after enrollment
Prevalence of Hematopoietic Stem Cells
Technique completed using special machine that utilizes lasers to separate and quantify various content of cell samples; used in this study to determine complete blood cell count (CBC) and peripheral hematopoietic progenitor cell concentration
Time frame: 6 weeks after enrollment
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Aug 2022 to primary completion in Nov 2023, 15 months.
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This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Andrews Research & Education Foundation