Health Trials

KeyScope Study in Uganda

ConditionAbdominal Neoplasm
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorDuke University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

significant comorbidities

previous major abdominal surgery

current pregnancy

Trial design

Design model

Single group

Treatments tested in this trial

  • KeySuite

    Device

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

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: KeySuiteExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Day of surgery

Secondary outcomes

1

Time to complete surgery

Length of surgery will be recorded

Time frame
Day of surgery
2

Estimated blood loss

Blood loss will be recorded

Time frame
Day of surgery
3

Surgical injuries and adverse events

Surgical injuries (device-related and unrelated) and other adverse events at the time of surgery will be recorded

Time frame
Day of surgery

Other outcomes

1

Surgical site infection

Any infections at the surgical site will be recorded and followed until resolution

Time frame
30 days
2

Post-operative complications

All post-operative complications will be recorded

Time frame
30 days
3

Mortality

Survival through 30 days

Time frame
30 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

Makerere University

Collaborator

Uganda Cancer Institute

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: