KeyScope Study in Uganda

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Not applicable

Age range

Not specified - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

12 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not applicable

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Other measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

Duke University

Study start

Jan 1, 2027 Estimated

Primary completion

Jun 30, 2027 Estimated

Study completion

Dec 30, 2027 Estimated

First posted

Jan 19, 2024 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts