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NCT06212570
KeyScope Study in Uganda
Conditions: Abdominal Neoplasm
Sex: All
Healthy volunteers: No
Phase: NA
Enrollment: 12
Sponsor: Duke University
Location: Uganda Cancer Institute Kampala
Summary
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
Inclusion Criteria:
* 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
* surgeon determine that laproscopic biopsy it technically appropriate
Exclusion Criteria:
* significant comorbidities
* previous major abdominal surgery
* current pregnancy
Source: ClinicalTrials.gov (NCT06212570). StuddyBuddy aggregates publicly available trial information.