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Intraoperative Ultrasound in Patients Undergoing Transsphenoidal Surgery for Pituitary Adenoma

NCT03284775 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2023-11-29

No results posted yet for this study

Summary

Pituitary adenoma can be difficult to cure with approximately a third of patients in contemporary series' undergoing incomplete resection. Over the last decade or so a handful of groups have described the use intraoperative ultrasound to improve resection. Although limited, these proof-of-concept studies suggest intraoperative ultrasound is a safe and effective technological adjunct to transsphenoidal surgery for pituitary adenoma.

In this prospective development study 30 adult patients will undergo transsphenoidal surgery for pituitary adenoma with prototype intraoperative ultrasound devices. The primary outcomes will be technical feasibility and device safety. The secondary outcomes will be complete versus incomplete radiological resection, endocrinological remission, the occurrence of postoperative complications, operating time, and length of stay.

Conditions

  • Pituitary Adenoma

Interventions

DEVICE

Intraoperative ultrasound

Patients will undergo transsphenoidal surgery in the usual manner except that an intraoperative ultrasound device will be available for use to better visualise the tumour and surrounding neurovascular structures.

Sponsors & Collaborators

  • University College, London

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-07
Primary Completion
2022-08-03
Completion
2023-08-02

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03284775 on ClinicalTrials.gov