KeyScope Study in Uganda

Not Applicable

Not yet recruiting

• Conditions: Abdominal Neoplasm
• Interventions: Device: KeySuite

• Registration Number: NCT06212570
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-27
• Study First Submitted QC: 2024-01-16
• Study First Posted: 2024-01-19
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-02-28
• Study Start: 2025-07-01
• Primary Completion: 2026-04-30
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
KeySuite	KeySuite	The KeyLoop and KeyScope devices will be used to perform intra-abdominal biopsies.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Time to complete surgery	Day of surgery	Length of surgery will be recorded

Trial Locations

Locations (1)

Uganda Cancer Institute; 🇺🇬 Kampala, Uganda