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NCT Number: NCT06212570

KeyScope Study in Uganda

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.

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Key information

Conditions

Abdominal Neoplasm Abdominal Neoplasms Neoplasms Neoplasms by Site

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KeySuite

Device

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

Primary outcomes

  1. Establish the clinical safety KeySuite

    Time frame: 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 outcomes

  1. Time to complete surgery

    Time frame: Day of surgery

    Length of surgery will be recorded

  2. Estimated blood loss

    Time frame: Day of surgery

    Blood loss will be recorded

  3. Surgical injuries and adverse events

    Time frame: Day of surgery

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

Other outcomes

  1. Surgical site infection

    Time frame: 30 days

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

  2. Post-operative complications

    Time frame: 30 days

    All post-operative complications will be recorded

  3. Mortality

    Time frame: 30 days

    Survival through 30 days

Study contacts

Contact information is provided by the study sponsor or research team.

Dana Giangiacomo

CONTACT

[email protected]

919-684-3821

Tamara Fitzgerald, MD, PhD

CONTACT

[email protected]

919-681-5077

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Makerere University
  • Uganda Cancer Institute

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 19, 2024
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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