An interventional study of KeySuite in Abdominal Neoplasm, sponsored by Duke University. Not yet recruiting at 1 site in Uganda. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Duke University · Not applicable, Interventional, and Diagnostic
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.
42 studies on the registry are indexed under Abdominal Neoplasms; 14 are open to participants now.
This study's planned enrollment of 12 is below the median of 78 across 26 interventional studies indexed under Abdominal Neoplasms.
Browse Abdominal Neoplasms studies →Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The KeyLoop and KeyScope devices will be used to perform intra-abdominal biopsies.
Device: KeySuite
KeyScope and KeyLoop will be used to perform biopsies of intra-abdominal masses and cancers.
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.
Time frame: Day of surgery
Time to complete surgery
Length of surgery will be recorded
Time frame: Day of surgery
Estimated blood loss
Blood loss will be recorded
Time frame: 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
Time frame: Day of surgery
Surgical site infection
Any infections at the surgical site will be recorded and followed until resolution
Time frame: 30 days
Post-operative complications
All post-operative complications will be recorded
Time frame: 30 days
Mortality
Survival through 30 days
Time frame: 30 days
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.