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Not Yet Recruiting 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06212570). StuddyBuddy aggregates publicly available trial information.