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Clinical Trials

The Department of Surgery doesn’t just excel in the operating room. Through our extensive and innovative research programs, we are also focused on the development of new techniques and therapies that promote better outcomes and improve the quality of life for patients following surgery. 

As part of that goal, the department’s surgeons are involved in groundbreaking clinical trials. In addition to their research value, clinical trials may also give patients access to new treatments that are not available anywhere else.

Learn more about our current clinical trials below or visit the Joint Clinical Trials Office at Weill Cornell Medicine and NewYork-Presbyterian.

This clinical trial is to evaluate the safety and efficacy of an investigational drug named emricasan (IDN-6556) in men and women who are 18 years or older who have been diagnosed with non-alcoholic steatohepatitis (NASH) fibrosis. 

Key Inclusion / Exclusion Criteria:

- Men and women who are 18 years of age and older. 

- Have Non-alcoholic Steatohepatitis (NASH) Fibrosis 

- Detailed eligibility reviewed when you contact the study team. 

This clinical trial is to evaluate the safety and efficacy of an investigational drug named emricasan (IDN-6556) in men and women who are 18 years or older who have been diagnosed with decompensated non-alcoholic steatohepatitis (NASH) cirrhosis. 

Key Inclusion / Exclusion Criteria:

   1. Men and women who are 18 years of age and older. 
   2. Have decompensated Non-alcoholic Steatohepatitis (NASH) cirrhosis. 
   3. Detailed eligibility reviewed when contacting the study team. 

This clinical trial is to evaluate an experimental (investigational) drug in men or women who have been diagnosed and recently hospitalized with decompensated liver cirrhosis and ascites. 
    

Key Inclusion / Exclusion Criteria:

- Men and women who are 18 years of age and older. 
- Individuals with decompensated cirrhosis and ascites. 
- Detailed eligibility reviewed when contacting the study team. 

This study is being done to answer the following question: Can we improve the chance of your leukemia going away (remission) and lower the chance of your leukemia coming back (relapsing) by combining two drugs for acute lymphoblastic leukemia? 

Key Inclusion / Exclusion Criteria:

Cohort (1) Patients Only: 

  • Age 60 or older
  • No prior therapy for ALL (*with minimal exceptions) 

Cohort 2 Patients Only: 

  • Age 18 or older 
  • Relapsed or refractory disease in salvage 1 or 2 

Cohort (1) and Cohort (2) Patients:

  • Detailed eligibility reviewed when you contact the study team. 

Over the last two decades, mechanical circulatory support devices (MCSDs) have been developed to augment or supplant failing myocardial performance.

Key Inclusion / Exclusion Criteria:

Inclusion criteria:

  • Patients with an FDA-approved MCSD implanted on or after March 1, 2006. Every patient who has signed consent and has received an eligible MCSD at a participating center will be enrolled, regardless of the reason of implantation (i.e., bridge-to-recovery, bridge-to-alternative bridge, bridge-to-clinical improvement for transplant eligibility, bridge-to-transplant, destination therapy)
  • Eligible devices include all of the following:
    • approved devices for any indications except through a registered clinical trial
    • INTERMACS-linked trial of investigational device or approved device for investigational indications, for which data will be entered via the INTERMACS framework
    • external trial of investigational device or approved device for investigational indications, for which data will be collected by an external group
    • compassionate use of investigational devices or approved devices outside of approved indications or clinical trials

Exlcusion criteria:

  • Currently incarcerated

This clinical trial is for men and women who have been diagnosed with compensated cirrhosis as a result of non-alcoholic steatohepatitis (NASH).

Key Inclusion / Exclusion Criteria:
  • Men and women who are 18 years of age and older. 
  • Must be diagnosed with NASH. 
  • Detailed eligibility reviewed when you contact the study team. 

This clinical trial is for patients with Advanced Prostate Cancer. The purpose of this study is to learn more about prostate cancer and:

Key Inclusion / Exclusion Criteria:

• Age 18 and older. 
• Histological or cytological confirmation of prostate adenocarcinoma 
• Detailed eligibility reviewed when you contact the study team. 

This is an observational study for men and women who have a body mass index (BMI) of greater than 30 kg/m2 and have a history of liver or gastrointestinal (GI) problems. 

Key Inclusion / Exclusion Criteria:
  • 18 years old and over
  • Have a BMI greater than 30 kg/m2
  • Have a history of problems with the liver or gastrointestinal tract 
  • Detailed eligibility reviewed when contacting the study team

The purpose of this research study is to collect long term safety information on HUMIRA® (adalimumab), a monoclonal antibody approved for the treatment of moderate to severely active ulcerative colitis (UC).

Key Inclusion / Exclusion Criteria:

A patient will be eligible for participation in this registry if he/she meets inclusion criteria 1 and 3 or 2 and 3: 
    
   1. An adult patient (18 years of age or older) with moderately to severely active Ulcerative Colitis (UC) as per the physician's assessment who has been prescribed HUMIRA®, without or in combination with an immunomodulator (IMM) (6-MP (6-Mercaptopurine) or AZA (Azathioprine)), according to the local product labeling and meets one of the following criteria: 
    
   ● Is currently taking HUMIRA® therapy, and has received at least 8 weeks of HUMIRA® therapy prior to registry entry and the physician can provide source documentation (if available and/or applicable) of Serious Adverse Events (SAEs), Adverse Events of Interests (AEIs), and dosing information since initiation of therapy; 
    
   OR 
    
   ● Is entering after participation in an Abbott or AbbVie sponsored UC study and has received continuous (no more than 70 consecutive days off drug) HUMIRA® therapy since initiation of therapy. 
    
   2. An adult patient (18 years of age or older) with moderately to severely active UC as per the physician's assessment who has been prescribed IMM (6-MP or AZA) therapy, is currently taking IMM (6-MP or AZA) therapy without a concurrent biologic, has received at least 12 consecutive weeks of IMM therapy prior to registry entry and the physician can provide source documentation (if available and/or applicable) of SAEs, AEIs, and dosing information since initiation of therapy. 
    
   3. Patient is capable of and willing to grant authorization for use/disclosure of data being collected and provided to AbbVie and to comply with the requirements of the Registry protocol.

Exclusion Criteria 

   ● On HUMIRA® therapy if they cannot be treated with HUMIRA® in accordance with the local product label or 
   ● On IMM (6-MP or AZA) therapy without a concurrent biologic if they cannot continue to be treated with IMM therapy. 

Patients should not be enrolled into the registry if they are being treated with any investigational agents and/or approved biologics other than HUMIRA®.

This is a prospective, single-arm, multicenter trial designed to further evaluate the performance of the MarrowStim™ PAD Kit to treat critical limb ischemia (CLI) in subjects deemed unsuitable for revascularization. If subjects become eligible for conventional revascularization (i.e.

Key Inclusion / Exclusion Criteria:
  • Men and women 21 years and older
  • Unilateral or bilateral lower extremity ischemia due to advanced peripheral arterial disease
  • Unsuitable for revascularization
  • Minor tissue loss (Rutherford Category 5) or ischemic rest pain (Rutherford Category 4) with ABI ≤ 0.6, or TBI ≤ 0.4, or TcPO2 ≤ 50 mm Hg

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