914.493.7000

Surgery: Clinical Research Program

Banner

Surgery: Clinical Studies Open For Enrollment 

Post-Market Registry in Europe and US for the Use of VascuCel

Eligibility

  • Male or female ≥18 years of age
  • Patient is a candidate for treatment with VascuCel per approved device indications.
  • Exclusion: No study specific exclusion criteria; patients treated per standard clinical practice

Enrollment Status: Open to enrollment

Study Information

ClinicalTrials.gov | NCT04906824

Principal Investigator

Romeo Mateo, MD

Contact for Study Screening

Anuritha.Tirumani@wmchealth.org

 

A Phase 3, Prospective, Randomized, Open-label, Adaptive Group Sequential, Multicenter Trial with Blinded Endpoint Assessment to Evaluate the Efficacy and Safety of PROTHROMPLEX TOTAL for the Reversal of Direct Oral Factor Xa Inhibitor-induced Anticoagulation in Patients Requiring Urgent Surgery/Invasive Procedure.

Eligibility

  • Participants at least 18 years of age at enrollment.
  • Participant currently on treatment with oral Factor Xa inhibitor (rivaroxaban, apixaban, edoxaban).
  • In the opinion of the surgeon, the participant requires an urgent surgery/procedure that is associated with high-risk of intraoperative bleeding within 15 hours from the last dose of Factor Xa inhibitor and requires a reversal agent for suspected direct oral Factor Xa inhibitor-related coagulopathy. 
  • For participants who are beyond the 15-hour window, eligibility requires proof of elevated plasma anti Factor Xa (FXa) levels using either specific direct oral anti-coagulant (DOAC)-calibrated (apixaban, rivaroxaban or edoxaban) anti-FXa levels of greater than (>) 75 nanograms per milliliter (ng/mL), or heparin calibrated anti-FXa assay levels of >0.5 international unit per milliliter (IU/mL) at screening.
  • Women of childbearing potential should have a negative pregnancy test documented prior to enrollment
  • Participant or legally authorized representative willing to sign e-consent/written informed consent form.

Enrollment Status: Pending site activation

Study Information

ClinicalTrials.gov | NCT05156983

Principal Investigator

Kartik Prabhakaran, MD

Contact for Study Screening

Falyn.Katzman@wmchealth.org

Christopher.Hall2@wmchealth.org

 

Profiling of plasma before and after anticoagulant therapy in patients diagnosed with Venous Thromboembolism (VTE)

Eligibility

  • Male or female 18 - 80 years of age
  • Able and willing to sign an informed consent
  • Cancer induced Thrombosis
  • Diagnosis of VTE (before and after anticoagulant therapy)
  • Exclusion: Unwilling to sign informed consent

Enrollment Status: Open to enrollment

Principal Investigator

Matthew Bronstein, MD

Contact for Study Screening

Falyn.Katzman@wmchealth.org

 

Phase 1/2, Open label & double blind randomized placebo-controlled study to assess the feasibility of BGC101 (EnEPC) in the treatment of peripheral arterial disease (PAD) with critical limb ischemia (CLI)

Eligibility

  • Male or female at least 18 years of age
  • Have the time and ability to complete the study and comply with instructions.
  • Non-pregnant and non-lactating female patients.
  • Have the clinical indications diagnostic of CLI based on Rutherford category 4-5
  • Exclusion: for matched healthy controls; Severe and uncorrected aorto-iliac and/or common femoral artery disease, i.e. absence of femoral pulse or monophasic common femoral artery doppler waveform, Concurrent therapy that, in the Investigator's opinion, would interfere with the evaluation of the feasibility of the study medication, Treatment with any investigational product within the last six months or enrollment in any active study involving the use of investigational devices or drugs and Presence of any other condition or circumstance that, in the judgment of the investigator, might negatively impact the outcomes of the treatment under investigation.

Enrollment Status: Open to enrollment

Study Information

ClinicalTrials.gov | NCT02805023

Principal Investigator

Igor Laskowski, MD

Contact for Study Screening

Anuritha.Tirumani@wmchealth.org

 

“Medtronic EndurAnt Stent Graft system vs ExcluDer endoprothesis: a global, prospectiVe, rANdomized Clinical trial in sac rEgression (ADVANCE Study)”

Eligibility

  • Male or female at least 20 years old
  • Subject and the treating physician agree that the subject will return for all required follow-up visits
  • Subject has an aneurysm diameter of:
    • o ≥ 5 cm (if woman)
    • o ≥ 5.5 cm (if man)
  • Exclusion: for matched healthy controls; Subject is participating in an investigational drug or device study which may bias or interfere with the endpoints and follow-up of this trial 
  • Subject has an estimated life expectancy of ≤ 3 years as judged by the investigator

Enrollment Status: Open to enrollment

Study Information

ClinicalTrials.gov | NCT05378347

Principal Investigator

Igor Laskowski, MD

Contact for Study Screening

Anuritha.Tirumani@wmchealth.org

 

Prospective Randomized Open Label Multicenter Phase IV Clinical Trial to Compare Transforming Powder Dressing (TPD) to Current Standard of Care (SOC) Dressing Therapies in Acute Partial Thickness Burn Wounds

Eligibility

  • Hospitalized patients, patients admitted for observation, and outpatients who are receiving acute burn care.
  • Men and non-pregnant/non-lactating women 18 to 65 years old.
  • Diagnosis of partial thickness burn wounds <20% TBSA.
  • Burn injury should be no more than 48 hours old when being consented for study enrollment.
  • Burn with no previous intervention except for initial first aid/triage.
  • Willing and able to comply with protocol-mandated scheduled clinical evaluations/study visits.
  • Exclusion criteria:
    • Known allergy or sensitivity to TPD product or its components.
    • Women who are pregnant, breast feeding, or planning to become pregnant during the study period.
    • Infected wounds (clinical diagnosis).
    • Presence of any full thickness (third degree) burn(s).
    • Electrical burns.
    • Heavily draining burns.
    • Concurrent clinical condition within the judgement of the clinician that would pose a health risk to patient, delay wound healing or otherwise influence outcome of study.

Enrollment Status: Open to enrollment

Study Information

ClinicalTrials.gov | NCT05424354

Principal Investigator

Joseph Turkowski, MD

Contact for Study Screening

Anuritha.Tirumani@wmchealth.org

 

Randomized Clinical Trial to Compare Transforming Powder and Standard of Care Dressing Therapies to Heal Diabetic Foot Ulcers

Eligibility

  • Men or non-pregnant/non-lactating women 18-89 years of age
  • Diagnosed with diabetes mellitus with Hgb A1C <12%
  • Diabetic foot ulcer present >30 days
  • Diabetic Foot Ulcer (DFU) classification: Wagner Grade 1 or 2 ulcers
  • Wound drainage is minimal or moderate
  • No clinically active wound infection (clinical diagnosis)
  • Exclusion criteria:
    • Known allergy to TPD
    • Highly exudative wounds
    • Wounds with necrosis unable to undergo debridement
    • Active gangrene
    • Body Mass Index (BMI) >45 kg/m2
    • Wounds impending surgical intervention (including revascularization or plastic surgery)
    • Untreated osteomyelitis
    • Soft tissue infection (based on clinical diagnosis)
    • Active Charcot arthropathy
    • Untreated HIV
    • Impending organ transplant

Enrollment Status: Open to enrollment

Study Information

ClinicalTrials.gov | NCT05046158

Principal Investigator

Igor Laskowski, MD

Contact for Study Screening

Anuritha.Tirumani@wmchealth.org