KeyScope Study in Uganda

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Abdominal Neoplasm
• Intervention / Treatment: Device: KeySuite

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dana Giangiacomo; Phone Number: 919-684-3821; Email: dana.giangiacomo@duke.edu
• Study Contact Backup: Name: Tamara Fitzgerald, MD, PhD; Phone Number: 919-681-5077; Email: tamara.fitzgerald@duke.edu

Study Locations

• Uganda
  • Kampala, Uganda
    • Uganda Cancer Institute
    • Contact: Nixon Niyonzima, PhD; Phone Number: +256 755 677 395; Email: nniyonzima@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KeySuite; The KeyLoop and KeyScope devices will be used to perform intra-abdominal biopsies.	Device: KeySuite; KeyScope and KeyLoop will be used to perform biopsies of intra-abdominal masses and cancers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establish the clinical safety KeySuite	This will be determined by whether or not the procedure was able to be completed laproscopically or had to be converted to open surgery.	Day of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to complete surgery	Length of surgery will be recorded	Day of surgery
Estimated blood loss	Blood loss will be recorded	Day of surgery
Surgical injuries and adverse events	Surgical injuries (device-related and unrelated) and other adverse events at the time of surgery will be recorded	Day of surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical site infection	Any infections at the surgical site will be recorded and followed until resolution	30 days
Post-operative complications	All post-operative complications will be recorded	30 days
Mortality	Survival through 30 days	30 days

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Makerere University; Uganda Cancer Institute
• Investigators: Principal Investigator: Tamara Fitzgerald, MD, PhD, Duke Health

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): March 30, 2028

Study Registration Dates

• First Submitted: November 27, 2023
• First Submitted That Met QC Criteria: January 16, 2024
• First Posted (Actual): January 19, 2024

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Abdominal Neoplasms
• Other Study ID Numbers: Pro00110170

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No