Surgery Clinical Trials Office

The Surgery Clinical Trials Office (SurgCTO) is available to collaborate with and provide support for investigators and their research teams in all phases of clinical research, including the organization, implementation, and completion of clinical research studies.

Our Mission

  • To provide quality staff and services for research that is responsive and appropriate to both the investigator and the needs of the community;
  • To promote public and professional education and awareness regarding clinical research;
  • To contribute to medical and intellectual advancements;
  • To contribute and uphold the missions of the University of Minnesota and the Department of Surgery.

 

Contact + Our Team Members

REQUEST FOR SERVICES

Dinnaken Office Building, Suite 150
925 Delaware St SE
Minneapolis, MN 55414
SurgCTO@umn.edu 

Phone: 612-624-7463
Fax: 612-624-0902

The staff is available Monday through Friday, during regular business hours. Extended and weekend hours can be available upon request.


Faculty & Staff

Arthur Matas, M.D. 
Clinical Research Director
612-624-1927

Mary Farnsworth, B.A., CCRC 
Operations Manager
612-624-9695

Nicholas Lemke, M.S.
Faculty Research Development Advisor
612-625-2687

Kristin Mathson, B.A., CCRP
Clinical Research Program Manager
612-626-5436

Marcia Brott, B.A., CCRP
Clinical Research Coordinator
612-625-1172

Shannon Jannatpour, MS, RDN, LDN, CLT, CCRP
Clinical Research Coordinator 
612-624-5746

Michelle Landeweer, B.S.
Data Coordinator
612-624-1601

Monica Myers, B.S., CCRP
Data Coordinator
612-301-1175

Alyssa Nelson
, B.S.
Clinical Research Coordinator
612-624-5453

Alison Oase
Clinical Trials Assistant
612-624-7463

Mattie Wagner, M.S.
Clinical Research Coordinator
612-626-2506

 

Services

We offer services in areas including financial, study start-up, study coordination, study closeout, and more.

Financial Management

  • Preparation of and assistance in negotiating contracts with industry sponsors
  • Budget development
  • Coordinate account set up with SPA
  • Coordinate purchasing and invoicing
  • Manage reimbursements for study subjects
  • Financial close-out

Study Start-Up

  • Coordinate feasibility surveys
  • Preparation and submission of Institutional Review Board materials such as:
    • Initial application and corresponding appendices
    • Informed Consent and HIPAA forms
    • Development of subject recruitment materials (flyers, letters, phone scripts)
  • Preparation and submission of materials for scientific review
  • Coordination of site initiation visits
  • Regulatory binder creation and organization
  • Development of data collection forms/source documents
  • Contract for goods and services to be provided by vendors

Study Coordination

  • Research participant recruitment and screening
  • Assistance with determining study eligibility
  • Garner informed consent
  • Schedule research procedures and visits
  • Facilitate research visits and assistance with data collection at study visits
  • Manage reimbursement for study subjects
  • Process samples and coordinate shipment or storage of research specimens
  • Preparation and submission of amendments, renewals, and other study documents
  • Facilitate study monitoring visits
  • Completion of Case Report Forms (CRFs)/eCRFs

Study Closeout

  • Coordination of study closeout visits
  • Verifying that studies meet IRB standards for study closure
  • Preparing and submitting IRB and other committee closure notification
  • Performing data resolution for data analysis
  • Facilitating research file and data storage

Rates

 

The Surgery Clinical Trials Office (SurgCTO) is a not-for-profit, Internal Sales Organization (ISO). Our fees are rate-based and regulated by University of Minnesota Controller’s office.

Investigators or departments using SurgCTO services are charged hourly for work completed. The amount of time required for each task listed in the Services section varies from project to project. Please contact our office to discuss.

Limited pro bono support is available for junior investigators conducting investigator-initiated studies and for investigators who have received a department of surgery pilot grants.

Research Projects

The Surgery Clinical Trials Office (SurgCTO) supports the research activities for the Surgery Division clinical faculty at the University of Minnesota. SurgCTO is currently conducting approximately 45 clinical trials in various phases of enrollment and follow-up with a mix of investigator-initiated, industry-sponsored, and government-sponsored trails.

There are active clinical research trials in the following divisions:

 

Cardiothoracic

  • BAL Pilot Study - Pilot study for Tracking Graft Antigen-Specific CD4+ T-cells in Lung Transplant Recipients
  • EXPAND Lung II - Trial to Evaluate the Safety and Effectiveness of The Portable Organ System (OCS™) Lung System for Recruiting, Preserving and Assessing Non-Ideal Donor Lungs for Transplantation
  • Human Valve Tissue - Pilot Study for Collecting Human Cardiac Valve Specimens in Autoimmune Cardiac Valve Inflammation
  • Intermacs - Interagency Registry for Mechanically Assisted Circulatory Support
  • MOMENTUM CAP - Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3™ Continued Access Protocol
  • Pedimacs - Pedimacs is the pediatric portion of Intermacs
  • TOP Registry - The Organ Care System (OCS) Lung Thoracic Organ Perfusion (TOP) Post Approval Study (PAS) Registry
  • ProAct-XAA prospective, randomized, active (warfarin) controlled, parallel-arm clinical trial to determine if patients with an On-X aortic valve can be maintained safely and effectively on the factor Xa inhibitor apixaban
  • HM3 SWIFTImplantation of the HeartMate 3 in Subjects with Heart Failure using Surgical Techniques Other Than Full Median Sternotomy
  • CentriMag FTW PASThe primary objective of this PAS is to report the proportion of patients surviving to 30 days post-CentriMag support or to hospital discharge, whichever is longer. For subjects who do not recover and are bridged to a heart transplant or a long-term assist device, the primary endpoint is survival to induction of anesthesia for the surgery.
  • OCS DCD Heart CAPThe Portable Organ Care System (OCS™) Heart For Resuscitation, Preservation, and Assessment of Hearts from Donors after Circulatory Death Continued Access Protocol (OCS DCD Heart CAP)

Gastroenterology/Bariatric

  • Right Colectomy - A Multi-Center Prospective Comparison of Intracorporeal and Extracorporeal Anastomoses for Minimally Invasive Right Colectomy
  • ADA - Bariatric Surgery and Adipose Inflammation Dysfunction and Type 2 Diabetes Mellitus
  • Hepatic Energy Fluxes - Hepatic Energy Fluxes in NASH and NAS Patients
  • VSG & NASH - Verticle Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis
  • Hepatic Artery Denervation - Evaluation of the Effect of Laparoscopic Hepatic Sympathetic Denervation on a Subset of Patients with Type 2 Diabetes Mellitus (Pending)
  • Colospan - Efficacy, and Safety of the CG-100 Intraluminal Bypass Device in Colorectal and Coloanal Anastomoses
  • PrevisEA - A Minimal-Rick, Multi-Center, Prospective, Clinical Trial to Evaluate the PrevisEA Device for Predicting Gastrointestinal Impairment

Solid Organ Transplant

  • Decision Aid: Preparing Liver Transplant Candidates for an Organ Offer Acceptance Decision
  • Donor Long-Term Follow Up
  • Patient Center Report Card
  • Microbiome PK: Microbiome and Immunosuppression: The Mission Study
  • BB3/ANG3777 - A Multicenter, Prospective, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study of BB3 to Reduce the Severity of Delayed Graft Function in Recipients of a Deceased Donor Kidney
  • HOPE Act - Observational Study of Solid Organ Transplantation Utilizing HIV-Positive Donors in HIV-Positive Recipients
  • KOAR - Evaluation of Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry
  • Liver PROTECT - TransMedics (OCS) Liver Trial: Preserving and Assessing Donor Livers for Transplantation
  • FREEDOM-1A randomized, controlled, multi-center, safety and efficacy study of FCR001 cell-based therapy relative to a tacrolimus and mycophenolate-based regimen in de novo living donor renal transplant recipients, and safety in FCR001 donors.
  • SCCa - Underlying Molecular Mechanisms in Development of Skin Squamous Cell Carcinoma in Transplant Recipients and General Population

Vascular

Humanitarian Use Device (HUD)

  • Enterra - HDE (Human Device Exemption) Enterra Therapy Gastric Stimulation