KeyScope Study in Uganda

Abdominal Neoplasm Clinical Trial

Official title:

KeyScope: First-In-Human Clinical Study for Cancer Diagnosis in Uganda

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06212570
• Other study ID #: Pro00110170
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Abdominal Neoplasm
• Abdominal Neoplasms

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