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KeyScope Study in Uganda

NCT ID: NCT06212570

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-04-01

Study Completion Date

2028-03-30

Brief Summary

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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

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Conditions

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Abdominal Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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KeySuite

The KeyLoop and KeyScope devices will be used to perform intra-abdominal biopsies.

Group Type EXPERIMENTAL

KeySuite

Intervention Type DEVICE

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

Interventions

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KeySuite

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

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Makerere University

OTHER

Sponsor Role collaborator

Uganda Cancer Institute

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tamara Fitzgerald, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke Health

Locations

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Uganda Cancer Institute

Kampala, , Uganda

Site Status

Countries

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Uganda

Central Contacts

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Tamara Fitzgerald, MD, PhD

Role: CONTACT

Phone: 919-681-5077

Email: [email protected]

Dana Giangiacomo

Role: CONTACT

Phone: 919-684-3821

Email: [email protected]

Facility Contacts

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Nixon Niyonzima, PhD

Role: primary

Other Identifiers

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Pro00110170

Identifier Type: -

Identifier Source: org_study_id