KeyScope Study in Uganda
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: KeySuite.
- Who it may be relevant to
- Registry conditions: Abdominal Neoplasm. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Uganda
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
KeyScope: First-In-Human Clinical Study for Cancer Diagnosis in Uganda
Overview
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.
Interventions
- Device KeySuite
KeyScope and KeyLoop will be used to perform biopsies of intra-abdominal masses and cancers.
Primary outcome measures
- Establish the clinical safety KeySuite [Time frame: Day of surgery]
Secondary outcome measures (3)
- Time to complete surgery [Time frame: Day of surgery]
- Estimated blood loss [Time frame: Day of surgery]
- Surgical injuries and adverse events [Time frame: Day of surgery]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Uganda · 1 center
- Uganda Cancer Institute — Kampala
Identifiers
NCT: NCT06212570 · Pro00110170