KeyScope Study in Uganda | NCT06212570

Studies
KeyScope Study in Uganda

NCT06212570

Sponsor

Duke University

Status

Not yet recruiting

Last Update Posted

Jun 3, 2026Actual

Enrollment

12Estimated

Phase

Not Applicable

Conditions

Abdominal Neoplasm

Interventions

KeySuite

Countries

Uganda

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2026Estimated

Primary Completion Date

Jun 30, 2027Estimated

Completion Date

Jun 30, 2028Estimated

First Submitted Date

Nov 27, 2023

First Submission Date that Met QC Criteria

Jan 16, 2024

First Posted Date

Jan 19, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2026

Last Update Posted Date

Jun 3, 2026Actual

Name	Class
Makerere University	OTHER
Uganda Cancer Institute	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
KeySuite	Experimental	The KeyLoop and KeyScope devices will be used to perform intra-abdominal biopsies.	Device: KeySuite

Interventions

Name	Type	Description	Arm Group Labels	Other Names
KeySuite	Device	KeyScope and KeyLoop will be used to perform biopsies of intra-abdominal masses and cancers.	KeySuite

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Time to complete surgery	Length of surgery will be recorded	Day of surgery
Estimated blood loss	Blood loss will be recorded	Day of surgery

Other Outcomes

Measure	Description	Time Frame
Surgical site infection	Any infections at the surgical site will be recorded and followed until resolution	30 days
Post-operative complications	All post-operative complications will be recorded

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tamara Fitzgerald, MD, PhD	Contact	919-681-5077		tamara.fitzgerald@duke.edu
Dana Giangiacomo	Contact	919-684-3821		dana.giangiacomo@duke.edu

Overall Officials

Name	Affiliation	Role
Tamara Fitzgerald, MD, PhD	Duke Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uganda Cancer Institute		Kampala			Uganda

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000008	Abdominal Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided