Clinical trial · Interventional
KeyScope Study in Uganda
KeyScope: First-In-Human Clinical Study for Cancer Diagnosis in Uganda
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abdominal Neoplasm | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KeySuite | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- KeySuite
- description
- The KeyLoop and KeyScope devices will be used to perform intra-abdominal biopsies.
- interventionNames
- Device: KeySuite
Primary outcomes (1)
- measure
- Establish the clinical safety KeySuite
- timeFrame
- Day of surgery
- description
- This will be determined by whether or not the procedure was able to be completed laproscopically or had to be converted to open surgery.
Secondary outcomes (3)
- measure
- Time to complete surgery
- timeFrame
- Day of surgery
- description
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available