Abdominal NeoplasmNCT06212570
KeyScope Study in Uganda
A study testing KeySuite in people with Abdominal Neoplasm, run by Duke University at 1 site in Uganda.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Abdominal Neoplasm
- What is being tested?
- KeySuite
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUganda
- Study dates
- 1 Sep 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- significant comorbidities
- previous major abdominal surgery
- current pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Uganda1 site
Uganda Cancer Institute
Kampala
Nixon Niyonzima, PhD, +256 755 677 395, nniyonzima@gmail.com
About this study
Official title: KeyScope: First-In-Human Clinical Study for Cancer Diagnosis 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.
- Conditions
- Abdominal Neoplasm
- Being tested
- KeySuite
- Medical subject headings
- Abdominal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KeySuiteDevice
KeyScope and KeyLoop will be used to perform biopsies of intra-abdominal masses and cancers.
| Study group | Role | What they receive |
|---|---|---|
| KeySuite | Experimental | The KeyLoop and KeyScope devices will be used to perform intra-abdominal biopsies. Receives: Device: KeySuite |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day of surgery
Secondary outcomes (3)
Time to complete surgery
Length of surgery will be recorded
Measured: Day of surgery
Estimated blood loss
Blood loss will be recorded
Measured: Day of surgery
Surgical injuries and adverse events
Surgical injuries (device-related and unrelated) and other adverse events at the time of surgery will be recorded
Measured: Day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start1 Sep 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal NeoplasmStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Makerere University, Uganda Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Tamara Fitzgerald, MD, PhD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06212570
- Sponsor's protocol ID
- Pro00110170
- Status last verified
- Jul 2026
- First submitted
- 27 Nov 2023
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KeyScope: First-In-Human Clinical Study for Cancer Diagnosis in Uganda
- ClinicalTrials.gov ID
- NCT06212570
- Acronym / sponsor ID
- Pro00110170
- Conditions
- Abdominal Neoplasm
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Makerere University, Uganda Cancer Institute
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KeySuite | Experimental | Device: KeySuiteThe KeyLoop and KeyScope devices will be used to perform intra-abdominal biopsies. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- significant comorbidities
- previous major abdominal surgery
- current pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KeySuiteKeyScope and KeyLoop will be used to perform biopsies of intra-abdominal masses and cancers. | Device | KeySuite |
Primary outcome
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.
3 secondary outcomes
Time to complete surgery
Time frame: Day of surgery
Estimated blood loss
Time frame: Day of surgery
Surgical injuries and adverse events
Time frame: Day of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tamara Fitzgerald, MD, PhD principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KeySuite in people with Abdominal Neoplasm, run by Duke University at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tamara Fitzgerald, MD, PhD (919-681-5077, tamara.fitzgerald@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish the clinical safety KeySuite (time frame: Day of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026; AzTrials last refreshed its copy on 28 Oct 2026.