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Clinical Trials: Surgery


A Phase 3B, Randomized, Double-Blind, Placebo-Controlled, Parallel-treatment Group, Multicenter Efficacy and Safety Study of Topical Diltiazem Hydrochloride 2% Cream in Subjects with Anal Fissure (IRB# BH-13-065)

(Surgery)
  • Principal Investor
    Kelly Tyler, MD
  • Summary

    The purpose of this study is to see if Diltiazam Cream 2% is effective to reduce Anal Fissure pain associated with defecation when given 3 times a day.  

  • More Information

    Eligibility:

    To be considered for this study you must be between 18-75 years old, have an anal fissure, and have pain at least twice a week after using the bathroom. You must call into a telephone system every day you are on the study and you must be willing to stop all other topical medications applied to the fissure for the duration of the study.

     

  • Study Site Location
    Baystate Medical Center
  • Contact
    Barbara Burkott, RN, BSN, CCRP
    413.794.1305
    Email

A Phase II Multi-Center, Parallel-Group, Randomized, Double Blind, Proof-of-Concept, Adaptive Study Investigating the Safety and Efficacy of THR-184 Administered via Intravenous Infusion in Patients at Increased Risk of Developing Cardiac Surgery Associated-Acute Kidney Injury (CSA-AKI) (IRB# 524174)

(Heart, Surgery)
  • Principal Investor
    John Rousou, MD
  • Summary

    The purpose of this study is to see if an investigational medication is effective to prevent acute kidney injury in patients who are undergoing cardiac surgery. 

    Subjects will receive 4 doses in total investigational drug of either THR-184 (2 different dose levels) or placebo.

    Subjects will be followed until 90 Days after surgery for safety measurements.

  • More Information

    Eligibility:

    In order to participate in this trial you must be at least 18 years old and having open heart surgery. 

    Participants must meet eligibility requirements that deem them to be at risk for acute kidney injury post-operatively.

  • Study Site Location
    Baystate Medical Center
  • Contact
    Jennifer Germain, RN, BSN, CCRC
    413.794.2672
    Email

A Phase III, Multicentre, Randomised, Double-Blind, Comparative Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil (600 mg every 8 hours) Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Complicated Bacterial Skin and Soft Tissue Infections With Evidence of Systemic Inflammatory Response or Underlying Comorbidities (IRB# BH-12-114)

(Infection, Surgery)
  • Principal Investor
    Patrick Lee, MD
  • Summary

    The purpose of this research study is to see how well a new drug, ceftaroline fosamil, works to treat complicated skin and soft tissue infections (cSSTIs) and how safe it is. In this research study, you will get either the study drug, ceftaroline fosamil or vancomycin and aztreonam.

  • More Information

    Eligibility:

    To participate in this study you must be aged 18 years and older, and have one of the following complicated skin and soft tissue infections (cSSTIs): cellulitis (skin infection), traumatic or surgical wound infection, major skin abscess (collection of pus) or burn infection.

  • Study Site Location
    Baystate Medical Center
  • Contact
    Barbara Burkott, RN, BSN, CCRP
    413.794.1305
    Email

A Post Market Observational Study to Obtain Additional Information on the Use of Cormatrix ECM for Pericardial Reconstruction (IRB# 589061)

(Heart, Surgery)
  • Principal Investor
    David Deaton, MD
  • Summary

    The purpose of this study is to gather additional information on CorMatrix ECM for Pericardial Closure.  This device has received FDA clearance and is intended to close and repair of the sac surrounding the heart during cardiac surgery. To participate in this study, the CorMatrix ECM device must be used during cardiac surgery.

  • Study Site Location
    Baystate Medical Center
  • Contact
    Barbara Burkott, RN, BSN, CCRP
    413.794.1305

A Randomized, Double-Blinded, Active-Controlled Study of CB-183,315 In Patients With Clostridium Difficile Associated Diarrhea (IRB# BH-12-161)

(Infection, Surgery)
  • Principal Investor
    Patrick Lee, MD
  • Summary

    The purpose of this research study is to look at the safety and effectiveness of the study drug or oral vancomycin against Clostridium difficile Associated Diarrhea (CDAD). 

  • More Information

    Eligibility:

    To participate in the study you must be age 18-89, have a positive C. difficile toxin test and have 3 unformed bowel movements.

  • Study Site Location
    Baystate Medical Center
  • Contact
    Barbara Burkott, RN, BSN, CCRP
    413.794.1305
    Email

A Randomized, double-blind, multicenter trial to evaluate the safety and efficacy of sequential (intravenous, oral) moxifloxacin versus comparator in pediatric subjects with complicated intra-abdominal infection (IRB# BH-10-113)

(Children's health, Surgery)
  • Principal Investor
    Patrick Lee, MD
  • Summary

    The purpose of this study is to find out if an antibiotic currently being given to adults, moxifloxacin, is safe and effective for children with complicated infections in the abdomen.  Participants in this trial will receive either moxifloxacin or ertapenem followed by amoxicillin/clavulanate orally.

  • More Information

    Eligibility:

    To participate in this trial, you must be age 6-17 and have a complicated intra-abdominal infection such as a burst appendix.

  • Study Site Location
    Baystate Medical Center
  • Contact
    Barbara Burkott, RN, BSN, CCRP
    413-794-1305
    Email

Minocycline plus Amiodarone versus Amiodarone monotherapy for the Prevention of Atrial Fibrillation after Cardiac Surgery (IRB# BH-09-176)

(Surgery, Heart)
  • Principal Investor
    A. Alameddine, MD
  • Summary

    The purpose of this study is to see if adding an FDA approved antibiotic, Minocycline in addition to standard therapy after cardiac surgery causes less irregular heart rates.  Patients participating in this study will have all standard drug therapies and might also receive Minocycline.

  • More Information

    Eligibility:

    In order to participate in this study you must be having cardiac surgery, without history of atrial fibrillation or strokes.

  • Study Site Location
    Baystate Medical Center
  • Contact
    Barbara Burkott, RN, BSN, CCRP
    413.794.1305

Natural Orifice Translumenal Endoscopic Surgery (NOTES) Transvaginal Cholecystectomy (IRB# IRB08-086)

(Surgery)
  • Principal Investor
    John Romanelli, MD
  • Summary

    The purpose of this study is to determine if an experimental surgery to remove the gallbladder through the vagina is a safe and effective.

  • More Information

    Eligibility:

    To participate in this study you must by a female, at least 18 years old, with no history of prior pelvic surgery (with the exception of C-section and tubal ligation).

  • Study Site Location
    Baystate Medical Center
  • Contact
    Barbara Burkott, RN, BSN, CCRP
    413.794.1305
    Email

Per-Oral Endoscopic Myotomy (POEM) for Esophageal Achalasia (IRB# BH-11-079)

(Surgery)
  • Principal Investor
    David Earle, MD
  • Summary

    The purpose of this study is to determine if an experimental minimally invasive surgery for achalasia is  safe and effective  to treat this condition. 

  • More Information

    Eligibility:

    To be eligible for this study you must be over 18 years old and have no history of prior esophageal surgery or perforation.

  • Study Site Location
    Baystate Medical Center
  • Contact
    Barbara Burkott, RN, BSN, CCRP
    413.794.1305
    Email