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.

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.

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

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:

We also provide support for Humanitarian Use Devices (HUDs).


Bariatric

For additional information about the below trial(s) please contact surgcto@umn.edu or 612-624-7463.

  • ADA - Bariatric Surgery and Adipose Inflammation Dysfunction and Type 2 Diabetes Mellitus
  • CHAAMPS - Bariatric Surgery in African American Males
  • ReCharge PAS - The Safety and Efficacy of vBloc Therapy Delivered by the Maestro Rechargeable System for the Treatment of Obesity

Cardiothoracic

For additional information about the below trial(s) please contact surgcto@umn.edu or 612-624-7463

  • 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
  • NuPulse - Feasibility Study of the Intravascular Ventricular Assist System (iVAS)
  • Pedimacs - Pedimacs is the pediatric portion of Intermacs
  • SUSTAIN-IT - Sustaining Quality of Life of the Aged: Heart Transplant or Mechanical Support
  • TOP Registry - The Organ Care System (OCS) Lung Thoracic Organ Perfusion (TOP) Post Approval Study (PAS) Registry

Solid Organ Transplant

  • Decision Aid
  • Donor Long-Term Follow Up
  • Patient Center Report Card

For additional information about the below trial(s) please contact surgcto@umn.edu or 612-624-7463.

  • ASTOUND - To Compare the Effects of Immediate-Release Tacrolimus and Astagraf XL on Donor-Specific Antibody Formation and the Development of Immune Activation in de Novo Kidney Transplant Recipients
  • BB3 - 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
  • CSL Behring - Efficacy and Safety of Human Plasma-derived C1-esterase Inhibitor as an add-on to Standard of Care for the Treatment of Refractory Antibody-Mediated Rejection (AMR) in Adult Renal Transplant Recipients
  • CONNEKT (Shire AMR) -  Study to Evaluate the Efficacy and Safety of Cinryze® for the Treatment of Acute Antibody-Mediated Rejection in Patients with Kidney Transplant
  • DeKAF - A Study of Factors That Affect Long-Term Kidney Transplant Function
  • Envarsus Rapid Metabolizers - An Observational Study to Determine If Early Tacrolimus Troughs Detect Rapid Tacrolimus Metabolizers
  • Envarsus - Comparison of the Cognitive and Motor Effects of Treatment Between and Immediate and Extended Release Tacrolimus Based Immunosuppression Regimen in Kidney Transplant Recipients
  • ENLIST - Evaluating Nulojix (Belatacept) Long-Term Safety in Transplant
  • 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
  • Lost Wages - Effect of Lost Wage Reimbursement to Potential Kidney Donors On Living Donation Rates 
  • SCCa - Underlying Molecular Mechanisms in Development of Skin Squamous Cell Carcinoma in Transplant Recipients and General Population
  • ValA vs ValG - ValGanciclovir Versus ValAcyclovir for Viral Prophylaxis in Kidney Transplantation

Vascular

For additional information about the below trial(s) please contact surgcto@umn.edu or 612-624-7463.

  • Valiant Evo - Valiant Evo US Clinical Trial
  • Low Dose - Development of Ultra-Low Dose CT Based Screening for Aortic Aneurysms
  • RelayPro - Study of the RelayPro Thoracic Stent-Graft in Subjects with an Acute, Complicated Type B Aortic Dissection

Humanitarian Use Device (HUD)

For additional information about the below trial(s) please contact surgcto@umn.edu or 612-624-7463.

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

Gastroenterology

For additional information about the below trial(s) please contact surgcto@umn.edu or 612-624-7463.

  • Right Colectomy - A Multi-Center Prospective Comparison of Intracorporeal and Extracorporeal Anastomoses for Minimally Invasive Right Colectomy

Contact

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

Robert Bailey, CCRC
Administrative Director
612-626-5436

Alison Oase
Clinical Trial Support Specialist
612-624-7463

Sara Eischen, B.A. 
Clinical Research Project Manager
612-626-2498

Mary Farnsworth, B.A., CCRC 
Clinical Research Project Manager
612-624-9695

Nicholas Lemke, M.S.
Clinical Research Project Manager
612-625-2687

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

Lauren Huffman, B.A., CCRP
Clinical Research Coordinator
612-626-2989

Becky Johnson, B.S.
Clinical Research Coordinator
612-625-2469

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

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

History & Milestones

1987

Kidney Transplant Research Office created by Dr. Arthur Matas. Dr Matas continued with what is currently considered the largest natural history database of kidney transplant information.

2002

The Kidney Transplant Research Office merged with heart, lung, liver and pancreas groups to form Transplant Information Services (TIS) and started to follow all solid organ transplant recipients and donors in one database.

2012

March 2012, TIS is acquired by Fairview Corporation. December 2012, the research portion becomes the Transplant Research Organization.

2017

Transplant Research Organization (TRO) officially rolls out as a department-wide resource and changes its name to the Surgery Clinical Trials Office (SurgCTO).

Celebrating 50 years of firsts

In 1963, Joyce Wallin received a kidney from her twin sister at the University of Minnesota to become the state’s first successful kidney transplant recipient.

In the 50 years since then, our transplant program has helped more than 8,000 kidney transplant patients and completed more than 13,000 organ transplants.

Our program is one of the largest and most experienced in the country, and we have an extraordinary legacy of excellence in patient care, surgical outcomes, research and training. We've performed many "world's first" transplantations, including intestinal, allo-islet cell, and pancreas—plus many more "firsts" in the state.

This fall, we are proud to look back on 50 years of transplant innovation while moving forward with research and innovation to improve the care of transplant recipients into the future.

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