HARMONY – Handheld Robot for Minimally Invasive Neurosurgery
Research type
Research Study
Full title
A handheld robot for minimally invasive neurosurgery – a single-site , open-label early feasibility and safety study (IDEAL Stage 1) in patients undergoing surgery for pituitary adenoma
IRAS ID
360322
Contact name
Andrew Tunstell
Contact email
Sponsor organisation
University College London (UCL)
ISRCTN Number
ISRCTN57194862
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
This study is evaluating the feasibility and safety of the Panda Surgical Handheld System during the standard-of-care endoscopic transsphenoidal surgery (eTSS) for the removal of symptomatic pituitary gland tumours (pituitary adenomas) in adult patients.
eTSS is performed through the nose and sphenoid sinus. However, the narrow nasal passage can make it difficult to access, cut, and remove tumour tissue, thus, increasing the risk of complications. The Panda Surgical Handheld System is a new robotic handheld device designed to improve the neurosurgeons’ dexterity (the ability to move hands or fingers with skill), precision and control during eTSS. There are currently no existing comparative devices addressing this unmet need.
This is a first-in-human clinical study evaluating the use of the Panda Surgical Handheld System, which will be used as part of the standard eTSS instruments. The device will assist surgeons in performing precise actions during the operation, without changing the standard surgical approach, and ensuring patient care remains within routine clinical practice. The use of the new medical device alongside standard instruments will allow for real-time comparison with the current gold standard.
This is an open-label, non-randomised, single-arm study conducted at a single hospital site. Adults (18 years and older) with a suspected pituitary adenoma (confirmed by a dedicated contrast-enhanced MRI scan) will be identified by the clinical neurosurgical and pituitary multidisciplinary teams and invited to participate. Participants will attend seven in-person visits as part of standard care. These visits will take place over approximately nine months (for each participant) and include consent, pre-surgical assessments, the surgery itself, and follow-up appointments. The study will recruit six participants to limit risk while still providing valuable initial data on the Panda Surgical Handheld System in terms of feasibility and safety.
REC name
South East Scotland REC 02
REC reference
26/SS/0054
Date of REC Opinion
30 Jun 2026
REC opinion
Further Information Favourable Opinion