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

Office Address:
Phillips Wagensteen Building

516 Delaware Street SE, Suite 8-150
Minneapolis, MN 55455
SurgCTO@umn.edu 

Mailing Address:
420 Delaware Street SE, MMC 206
Minneapolis, MN 55455

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

Clinical Research Director

Director of Research

Faculty Research Development Advisor

Clinical Research Program Managers

Clinical Research Coordinators

Data Coordinator

Clinical Trials Assistant

 

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 110+ human subjects research projects 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 Surgery
  • Colon & Rectal Surgery 
  • Critical Care
  • Gastrointestinal/Bariatric Surgery
  • MN Consortium for Autonomic Neuromodulation
  • Solid Organ Transplant
  • Surgical Oncology
  • Vascular Surgery

 

Cardiothoracic

  • BAL Pilot Study - Pilot study for Tracking Graft Antigen-Specific CD4+ T-cells in Lung Transplant Recipients
  • 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
  • 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.

Colon & Rectal Surgery

  • 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
  • Building a Robotic Surgical Video Registry for Future Use in Surgical Automation - The purpose of building this registry is to house a collection of videos of surgeries performed by surgeons using current laparoscopic/robotic modalities within various surgical specialties, including general surgery, colon, and rectal surgery, gynecology, and urology (among others) at the MHealth Fairview University of Minnesota Medical Center.  

Gastroenterology/Bariatric

  • 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
  • NIVA - Observational study to compare Non-Invasive Venous waveform Analysis (NIVA) with Pulmonary Capillary Wedge Pressure (PCWP) during cardiac catheterization.

MN Consortium for Autonomic Neuromodulation

  • TARGET BP I - Randomized, blinded, multi-center, international, sham-procedure controlled trial, comparing renal denervation performed with the Peregrine System Kit in the treatment group to the sham control group.

Solid Organ Transplant

  • Donor Long-Term Follow Up
  • Factures and Bone Disease in Living Kidney Donors - The objective of this study is to determine whether or not prior living kidney donors have an increased risk of bone fractures. The study will also determine bone structure and health in prior living donors as compared to matched controls.
  • IMAGINE - A pivotal phase 3 trial to evaluate the safety and efficacy of Clazakizumab for the treatment of chronic active antibody-mediated rejection in kidney transplant recipients. 
  • cfDNA - The objective of this study is to determine whether cell-free DNA (cf-DNA) measurement can be used as a biomarker for the successful treatment of acute rejection (AR) episode after kidney transplantation.
  • The Mission Study - Microbiome PK: Microbiome and Immunosuppression
  • HOPE Act - Observational Study of Solid Organ Transplantation Utilizing HIV-Positive Donors in HIV-Positive Recipients
  • HOPE in Action - Trial of HIV+ Deceased Donor Liver Transplants for HIV+ Recipients
  • KOAR - Evaluation of Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry
  • FREEDOM-1A randomized, controlled, multi-center, safety and efficacy study of FCR001 cell-based therapy relative to tacrolimus and mycophenolate-based regimen in de novo living donor renal transplant recipients, and safety in FCR001 donors.

Surgical Oncology

  • NOLA (NeuWave Observational Liver Ablation) Registry
  • Short-Term Global Surgery and Physician Burnout - The purpose of this study is to determine whether Short-Term Global Surgery (STGS) experience is associated with improvement in physician burnout measures.

Humanitarian Use Device (HUD)

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