KeyScope Study in Uganda

Duke University

Status: Begins enrollment this month

Conditions: Abdominal Neoplasm

Treatments: Device: KeySuite

Study type: Interventional

Funder types: Other

Identifiers

NCT06212570

Pro00110170

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

KeySuite

Experimental group

Description:

The KeyLoop and KeyScope devices will be used to perform intra-abdominal biopsies.

Treatment:

Device: KeySuite