Trial Outcomes & Findings for Da Vinci Transoral Robotic-assisted Surgery of Pituitary Gland (NCT NCT02743442)

Last Updated: 2021-03-29

Results Overview

Number of patients in which the entire sella turcica (including its anterior face) is seen during surgery and reached by the robotic arms

Recruitment status

TERMINATED

Study phase

Target enrollment

8 participants

Primary outcome timeframe

1 day

Results posted on

2021-03-29

Participant Flow

Participant milestones

Participant milestones
Measure	Transoral Surgery da Vinci® Si™ single arm
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Da Vinci Transoral Robotic-assisted Surgery of Pituitary Gland

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Transoral Surgery n=8 Participants The study is a single arm : all patients were treated with da Vinci surgical procedure.
Age, Continuous	46.25 years STANDARD_DEVIATION 15.9 • n=39 Participants
Sex: Female, Male Female	4 Participants n=39 Participants
Sex: Female, Male Male	4 Participants n=39 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants
Race (NIH/OMB) Asian	0 Participants n=39 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants
Race (NIH/OMB) Black or African American	0 Participants n=39 Participants
Race (NIH/OMB) White	0 Participants n=39 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=39 Participants
Region of Enrollment France	8 participants n=39 Participants
Size of the lesion before surgery	30.75 millimeters STANDARD_DEVIATION 6.14 • n=39 Participants

PRIMARY outcome

Timeframe: 1 day

Population: Among the 8 patients enrolled in this study, 7 were operated using the Vinci robot. The surgery was canceled for one patient with acute coronary syndrome (a serious adverse event not related to the study).

Number of patients in which the entire sella turcica (including its anterior face) is seen during surgery and reached by the robotic arms

Outcome measures

Outcome measures
Measure	Transoral Surgery n=7 Participants Surgery of the pituitary adenoma via a transoral approach assisted by the da Vinci® Si™ robot
Number of Patients Operated Via da Vinci Robot	7 participants

SECONDARY outcome

Timeframe: 3 hours

Total duration of surgery: installation, mucosal time, sphenoidal time, resection and closure

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

An adverse event occurring after the procedure is serious if it causes death, endangers the life of the person who is suitable for research, requires or prolongs hospitalization, causes a significant handicap, results in a congenital malformation, or is considered medically significant.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 month

Duration of hospitalization after surgery

Outcome measures

Outcome data not reported

Adverse Events

Transoral Surgery

Serious events: 4 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Transoral Surgery n=8 participants at risk Surgery of the pituitary adenoma via a transoral approach assisted by the da Vinci® Si™ robot
Surgical and medical procedures Complication of neurological intervention	12.5% 1/8 • Number of events 1 • 6 months Definition of an adverse event: any harmful manifestation occurring in a person who is amenable to research involving the human person, whether or not the event is related to the research or product to which the research relates. Definition of a serious adverse event: any adverse event that causes death, is life-threatening, requires hospitalization or prolongation, causes disability, results in a congenital malformation, and any event considered medically significant.
Surgical and medical procedures Injury, poisoning and complications of interventions	25.0% 2/8 • Number of events 2 • 6 months Definition of an adverse event: any harmful manifestation occurring in a person who is amenable to research involving the human person, whether or not the event is related to the research or product to which the research relates. Definition of a serious adverse event: any adverse event that causes death, is life-threatening, requires hospitalization or prolongation, causes disability, results in a congenital malformation, and any event considered medically significant.
Cardiac disorders Injuries and complications related to an intervention	12.5% 1/8 • Number of events 1 • 6 months Definition of an adverse event: any harmful manifestation occurring in a person who is amenable to research involving the human person, whether or not the event is related to the research or product to which the research relates. Definition of a serious adverse event: any adverse event that causes death, is life-threatening, requires hospitalization or prolongation, causes disability, results in a congenital malformation, and any event considered medically significant.
Vascular disorders Stroke	12.5% 1/8 • Number of events 1 • 6 months Definition of an adverse event: any harmful manifestation occurring in a person who is amenable to research involving the human person, whether or not the event is related to the research or product to which the research relates. Definition of a serious adverse event: any adverse event that causes death, is life-threatening, requires hospitalization or prolongation, causes disability, results in a congenital malformation, and any event considered medically significant.

Other adverse events

Other adverse events
Measure	Transoral Surgery n=8 participants at risk Surgery of the pituitary adenoma via a transoral approach assisted by the da Vinci® Si™ robot
Endocrine disorders Diabetes insipidus	37.5% 3/8 • Number of events 3 • 6 months Definition of an adverse event: any harmful manifestation occurring in a person who is amenable to research involving the human person, whether or not the event is related to the research or product to which the research relates. Definition of a serious adverse event: any adverse event that causes death, is life-threatening, requires hospitalization or prolongation, causes disability, results in a congenital malformation, and any event considered medically significant.
Nervous system disorders Headaches	62.5% 5/8 • Number of events 5 • 6 months Definition of an adverse event: any harmful manifestation occurring in a person who is amenable to research involving the human person, whether or not the event is related to the research or product to which the research relates. Definition of a serious adverse event: any adverse event that causes death, is life-threatening, requires hospitalization or prolongation, causes disability, results in a congenital malformation, and any event considered medically significant.
Respiratory, thoracic and mediastinal disorders Epistaxis	12.5% 1/8 • Number of events 1 • 6 months Definition of an adverse event: any harmful manifestation occurring in a person who is amenable to research involving the human person, whether or not the event is related to the research or product to which the research relates. Definition of a serious adverse event: any adverse event that causes death, is life-threatening, requires hospitalization or prolongation, causes disability, results in a congenital malformation, and any event considered medically significant.
Gastrointestinal disorders Nausea/vomiting	25.0% 2/8 • Number of events 2 • 6 months Definition of an adverse event: any harmful manifestation occurring in a person who is amenable to research involving the human person, whether or not the event is related to the research or product to which the research relates. Definition of a serious adverse event: any adverse event that causes death, is life-threatening, requires hospitalization or prolongation, causes disability, results in a congenital malformation, and any event considered medically significant.
General disorders Laryngeal pain	37.5% 3/8 • Number of events 3 • 6 months Definition of an adverse event: any harmful manifestation occurring in a person who is amenable to research involving the human person, whether or not the event is related to the research or product to which the research relates. Definition of a serious adverse event: any adverse event that causes death, is life-threatening, requires hospitalization or prolongation, causes disability, results in a congenital malformation, and any event considered medically significant.
Eye disorders Visual trouble	37.5% 3/8 • Number of events 3 • 6 months Definition of an adverse event: any harmful manifestation occurring in a person who is amenable to research involving the human person, whether or not the event is related to the research or product to which the research relates. Definition of a serious adverse event: any adverse event that causes death, is life-threatening, requires hospitalization or prolongation, causes disability, results in a congenital malformation, and any event considered medically significant.
General disorders Asthenia	12.5% 1/8 • Number of events 1 • 6 months Definition of an adverse event: any harmful manifestation occurring in a person who is amenable to research involving the human person, whether or not the event is related to the research or product to which the research relates. Definition of a serious adverse event: any adverse event that causes death, is life-threatening, requires hospitalization or prolongation, causes disability, results in a congenital malformation, and any event considered medically significant.
Gastrointestinal disorders Dysphagia	12.5% 1/8 • Number of events 1 • 6 months Definition of an adverse event: any harmful manifestation occurring in a person who is amenable to research involving the human person, whether or not the event is related to the research or product to which the research relates. Definition of a serious adverse event: any adverse event that causes death, is life-threatening, requires hospitalization or prolongation, causes disability, results in a congenital malformation, and any event considered medically significant.
General disorders Fever	12.5% 1/8 • Number of events 1 • 6 months Definition of an adverse event: any harmful manifestation occurring in a person who is amenable to research involving the human person, whether or not the event is related to the research or product to which the research relates. Definition of a serious adverse event: any adverse event that causes death, is life-threatening, requires hospitalization or prolongation, causes disability, results in a congenital malformation, and any event considered medically significant.
Nervous system disorders Post-lumbar puncture syndrome	12.5% 1/8 • Number of events 1 • 6 months Definition of an adverse event: any harmful manifestation occurring in a person who is amenable to research involving the human person, whether or not the event is related to the research or product to which the research relates. Definition of a serious adverse event: any adverse event that causes death, is life-threatening, requires hospitalization or prolongation, causes disability, results in a congenital malformation, and any event considered medically significant.
Psychiatric disorders Anxiety	12.5% 1/8 • Number of events 1 • 6 months Definition of an adverse event: any harmful manifestation occurring in a person who is amenable to research involving the human person, whether or not the event is related to the research or product to which the research relates. Definition of a serious adverse event: any adverse event that causes death, is life-threatening, requires hospitalization or prolongation, causes disability, results in a congenital malformation, and any event considered medically significant.
Skin and subcutaneous tissue disorders Rash	12.5% 1/8 • Number of events 1 • 6 months Definition of an adverse event: any harmful manifestation occurring in a person who is amenable to research involving the human person, whether or not the event is related to the research or product to which the research relates. Definition of a serious adverse event: any adverse event that causes death, is life-threatening, requires hospitalization or prolongation, causes disability, results in a congenital malformation, and any event considered medically significant.
Nervous system disorders Pneumocephalus	12.5% 1/8 • Number of events 1 • 6 months Definition of an adverse event: any harmful manifestation occurring in a person who is amenable to research involving the human person, whether or not the event is related to the research or product to which the research relates. Definition of a serious adverse event: any adverse event that causes death, is life-threatening, requires hospitalization or prolongation, causes disability, results in a congenital malformation, and any event considered medically significant.
Endocrine disorders Corticotropin deficiency	12.5% 1/8 • Number of events 1 • 6 months Definition of an adverse event: any harmful manifestation occurring in a person who is amenable to research involving the human person, whether or not the event is related to the research or product to which the research relates. Definition of a serious adverse event: any adverse event that causes death, is life-threatening, requires hospitalization or prolongation, causes disability, results in a congenital malformation, and any event considered medically significant.
Gastrointestinal disorders Constipation	12.5% 1/8 • Number of events 1 • 6 months Definition of an adverse event: any harmful manifestation occurring in a person who is amenable to research involving the human person, whether or not the event is related to the research or product to which the research relates. Definition of a serious adverse event: any adverse event that causes death, is life-threatening, requires hospitalization or prolongation, causes disability, results in a congenital malformation, and any event considered medically significant.
Eye disorders Paralysis of the nerve III	12.5% 1/8 • Number of events 1 • 6 months Definition of an adverse event: any harmful manifestation occurring in a person who is amenable to research involving the human person, whether or not the event is related to the research or product to which the research relates. Definition of a serious adverse event: any adverse event that causes death, is life-threatening, requires hospitalization or prolongation, causes disability, results in a congenital malformation, and any event considered medically significant.
Injury, poisoning and procedural complications Pain at the incision site	12.5% 1/8 • Number of events 1 • 6 months Definition of an adverse event: any harmful manifestation occurring in a person who is amenable to research involving the human person, whether or not the event is related to the research or product to which the research relates. Definition of a serious adverse event: any adverse event that causes death, is life-threatening, requires hospitalization or prolongation, causes disability, results in a congenital malformation, and any event considered medically significant.
Ear and labyrinth disorders Vertigo	12.5% 1/8 • Number of events 1 • 6 months Definition of an adverse event: any harmful manifestation occurring in a person who is amenable to research involving the human person, whether or not the event is related to the research or product to which the research relates. Definition of a serious adverse event: any adverse event that causes death, is life-threatening, requires hospitalization or prolongation, causes disability, results in a congenital malformation, and any event considered medically significant.
Musculoskeletal and connective tissue disorders Torticollis	12.5% 1/8 • Number of events 1 • 6 months Definition of an adverse event: any harmful manifestation occurring in a person who is amenable to research involving the human person, whether or not the event is related to the research or product to which the research relates. Definition of a serious adverse event: any adverse event that causes death, is life-threatening, requires hospitalization or prolongation, causes disability, results in a congenital malformation, and any event considered medically significant.

Additional Information

Dr Amélie Yavchitz (deputy head of the clinical research unit)

Fondation Ophtalmologique A. de Rothschild

Phone: +33148036454

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place