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KeyScope Study in Uganda

NCT06212570 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-12-26

No results posted yet for this study

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

DEVICE

KeySuite

KeyScope and KeyLoop will be used to perform biopsies of intra-abdominal masses and cancers.

Sponsors & Collaborators

  • Makerere University

    collaborator OTHER

  • Uganda Cancer Institute

    collaborator OTHER

  • Duke University

    lead OTHER

Principal Investigators

  • Tamara Fitzgerald, MD, PhD · Duke Health

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2027-03-30
Completion
2028-03-30

Countries

  • Uganda

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06212570 on ClinicalTrials.gov