KeyScope Study in Uganda
KeyScope: First-In-Human Clinical Study for Cancer Diagnosis in Uganda
1 other identifier
interventional
12
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2023
CompletedFirst Posted
Study publicly available on registry
January 19, 2024
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 30, 2028
December 26, 2025
December 1, 2025
12 months
November 27, 2023
December 19, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Time to complete surgery
Day of surgery
Estimated blood loss
Day of surgery
Surgical injuries and adverse events
Day of surgery
Other Outcomes (3)
Surgical site infection
30 days
Post-operative complications
30 days
Mortality
30 days
Study Arms (1)
KeySuite
EXPERIMENTALThe KeyLoop and KeyScope devices will be used to perform intra-abdominal biopsies.
Interventions
KeyScope and KeyLoop will be used to perform biopsies of intra-abdominal masses and cancers.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- significant comorbidities
- previous major abdominal surgery
- current pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- Makerere Universitycollaborator
- Uganda Cancer Institutecollaborator
Study Sites (1)
Uganda Cancer Institute
Kampala, Uganda
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tamara Fitzgerald, MD, PhD
Duke Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2023
First Posted
January 19, 2024
Study Start
April 1, 2026
Primary Completion (Estimated)
March 30, 2027
Study Completion (Estimated)
March 30, 2028
Last Updated
December 26, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share