NCT06212570

KeyScope Study in Uganda

KeyScope: First-In-Human Clinical Study for Cancer Diagnosis in Uganda

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Abdominal Neoplasm

Interventions

Type	Name	Description
DEVICE	KeySuite	KeyScope and KeyLoop will be used to perform biopsies of intra-abdominal masses and cancers.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-03-30
• Completion: 2028-03-30
• First posted: 2024-01-19
• Last updated: 2025-12-26

Locations

1 site across 1 country: Uganda