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Trial Title:
KeyScope Study in Uganda
NCT ID:
NCT06212570
Condition:
Abdominal Neoplasm
Conditions: Official terms:
Abdominal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
KeySuite
Description:
KeyScope and KeyLoop will be used to perform biopsies of intra-abdominal masses and
cancers.
Arm group label:
KeySuite
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Uganda Cancer Institute
Address:
City:
Kampala
Country:
Uganda
Contact:
Last name:
Nixon Niyonzima, PhD
Phone:
+256 755 677 395
Email:
nniyonzima@gmail.com
Start date:
January 1, 2025
Completion date:
September 30, 2026
Lead sponsor:
Agency:
Duke University
Agency class:
Other
Collaborator:
Agency:
Makerere University
Agency class:
Other
Collaborator:
Agency:
Uganda Cancer Institute
Agency class:
Other
Source:
Duke University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06212570
