Abdominal Neoplasm
Conditions
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.
Interventions
DEVICEKeySuite
KeyScope and KeyLoop will be used to perform biopsies of intra-abdominal masses and cancers.
Sponsors
Duke University
Makerere University
Uganda Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Establish the clinical safety KeySuite | Day of surgery | 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
| Measure | Time frame | Description |
|---|---|---|
| Time to complete surgery | Day of surgery | Length of surgery will be recorded |
| Estimated blood loss | Day of surgery | Blood loss will be recorded |
| Surgical injuries and adverse events | Day of surgery | Surgical injuries (device-related and unrelated) and other adverse events at the time of surgery will be recorded |
Countries
Uganda
Contacts
CONTACTTamara Fitzgerald, MD, PhD
CONTACTDana Giangiacomo
PRINCIPAL_INVESTIGATORTamara Fitzgerald, MD, PhD
Duke Health
Outcome results
None listed