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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06212570
Other study ID # Pro00110170
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 1, 2025
Est. completion date September 30, 2026

Study information

Verified date January 2024
Source Duke University
Contact Tamara Fitzgerald, MD, PhD
Phone 919-681-5077
Email tamara.fitzgerald@duke.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 12
Est. completion date September 30, 2026
Est. primary completion date September 30, 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
KeySuite
KeyScope and KeyLoop will be used to perform biopsies of intra-abdominal masses and cancers.

Locations

Country Name City State
Uganda Uganda Cancer Institute Kampala

Sponsors (3)

Lead Sponsor Collaborator
Duke University Makerere University, Uganda Cancer Institute

Country where clinical trial is conducted

Uganda, 

Outcome

Type Measure Description Time frame Safety issue
Other Surgical site infection Any infections at the surgical site will be recorded and followed until resolution 30 days
Other Post-operative complications All post-operative complications will be recorded 30 days
Other Mortality Survival through 30 days 30 days
Primary 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 Time to complete surgery Length of surgery will be recorded Day of surgery
Secondary Estimated blood loss Blood loss will be recorded Day of surgery
Secondary Surgical injuries and adverse events Surgical injuries (device-related and unrelated) and other adverse events at the time of surgery will be recorded Day of surgery
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