NCT05338125

Brief Summary

Measurment of electrophysiological properties of the human pituitary gland during removal of a pituitary adenoma. Assessment if these properties are sufficient for intra-operative identification of different tissues.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2021

Completed
6 months until next milestone

First Posted

Study publicly available on registry

April 20, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2023

Completed
Last Updated

March 13, 2023

Status Verified

March 1, 2023

Enrollment Period

2.2 years

First QC Date

November 3, 2021

Last Update Submit

March 9, 2023

Conditions

Pituitary AdenomaPituitary TumorDiabetes Insipidus Cranial TypeEndocrine; Deficiency

Keywords

Electrophysiology

Outcome Measures

Primary Outcomes (1)

  • Electrophysiological properties

    Electrophysiological properties of the human pituitary gland

    Day 0

Secondary Outcomes (2)

  • Endocrine remission

    6 months postoperative

  • Endocrine deficiencies

    6 months postoperative

Study Arms (1)

Intervention arm

EXPERIMENTAL

Patients undergoing the extra intra-operative electrophysiological measurement

Procedure: Micro-electrode measurement

Interventions

Micro-electrode measurementPROCEDURE

Electrophysiological measurement with single-unit micro-electrode

Intervention arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients undergoing transsphenoidal surgery for pituitary adenoma.
  • Identification of the posterior lobe on preoperative MRI. This is most common in patients with micro-adenomas or small macroadenomas.
  • Age \>18 years

You may not qualify if:

  • Emergency surgery
  • Cognitive impairments
  • Pregnancy
  • Pre-existing diabetes insipidus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leiden University Medical Center

Leiden, 2333ZA, Netherlands

Location

MeSH Terms

Conditions

Pituitary NeoplasmsDiabetes Insipidus, Neurogenic

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHypothalamic NeoplasmsSupratentorial NeoplasmsBrain NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypothalamic DiseasesPituitary DiseasesEndocrine System DiseasesDiabetes InsipidusKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Pilot proof-of-concept study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

November 3, 2021

First Posted

April 20, 2022

Study Start

December 10, 2020

Primary Completion

March 9, 2023

Study Completion

March 9, 2023

Last Updated

March 13, 2023

Record last verified: 2023-03

Locations

NL(1)