KeyScope Study in Uganda

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorDuke University

About this trial

KeyScope and KeyLoop (collectively called KeySuite) are laparoscopic prototypes that the investigators have designed for the resources, needs and challenges of low- and middle- income countries (LMICs). KeyScope is a laparoscope that plugs into a laptop computer to display images during surgery. It links to a telementoring application so that experienced surgeons can mentor surgeons in capacity-building partnerships. KeyLoop is a laparoscopic retractor that lifts the abdominal wall during surgery, obviating the need for a constant power supply and medical-grade carbon dioxide.

The investigators will perform a clinical First-in-Human study at the Uganda Cancer Institute. Ugandan surgeons will use the KeySuite devices to perform biopsies of intra-abdominal tumors.

Eligibility criteria

Qualifiers

diagnosis of intra-abdominal mass suspicious for cancer

body mass index (BMI) of 18-30

weight 20-100kg

biopsy necessary to determine cancer diagnosis and classify pathology

Disqualifiers

significant comorbidities

previous major abdominal surgery

current pregnancy

Trial design

Treatments tested in this trial

  • KeySuite

Treatment groups

12 Participants
are divided into 1 treatment group

Sponsors and collaborators

Duke University

Lead sponsor

Makerere University

Collaborator

Uganda Cancer Institute

Collaborator