Hernia, Inguinal
Conditions
Brief summary
The purpose of this study is to assess safety and performance of the OTTAVA System, through 30 days postoperative, in participants undergoing robotic-assisted inguinal hernia repair (IHR).
Interventions
DEVICEOTTAVA Robotic System
Participants will undergo the IHR procedure using OTTAVA Robotic System.
Sponsors
Auris Health, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects must satisfy all inclusion criteria to be eligible for enrollment: 1. Willing and able to provide informed consent 2. A minimum of 22 years old at time of consent 3. Scheduled for elective primary inguinal hernia repair 4. American Society of Anesthesiologists (ASA) classification I, II, or III 5. Weight less than 227 kilograms (500 pounds)
Exclusion criteria
Subjects who meet any of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Achieving Procedure Completion Without Conversion | Intraoperative | Number of participants achieving procedure completion without conversion will be reported. |
| Number of Participants Experiencing Intraoperative and Postoperative Device or Procedure-Related Complications Greater than or Equal to (>=) Clavien-Dindo Grade III through 30 Days Post-Procedure | Intraoperative through 30 days post-procedure | The Clavien-Dindo classification for surgical complications provides a standardized, reproducible means for describing surgical complications based on described therapy for treatment. Clavien-Dindo grade III complications include those complications that require surgical, endoscopic, or radiological intervention. The interventions that are not given under general anesthesia are grade III A and the interventions given under general anesthesia are grade III B complications. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Needing Blood Transfusion | Intraoperative, Up to 30 days post-procedure | Number of participants needing blood transfusions will be reported. |
| Number of Units of Blood Transfusion | Intraoperative, Up to 30 days post-procedure | Number of units of blood transfusion will be reported. |
| Number of Participants Experiencing Device Malfunction | Intraoperative | Device malfunction is defined as a failure of an investigational medical device to perform in accordance with its intended purpose when used in accordance with the instructions for use or clinical investigation plan. |
| Number of Participants with Adverse Events (AE) through 30 Days Post-Procedure | Up to 30 days post-procedure | An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. |
| Number of Participants with Hospital Readmission | Up to 30 days post-procedure | Number of participants getting admitted to hospital again after discharge within 30 days post-procedure will be reported. |
| Number of Participants with Reoperations | Up to 30 days post-procedure | Number of participants with reoperations including any procedures performed within 30 days that are directly related to the index procedure will be reported. |
| Mortality | Intraoperative, Up to 30 days post-procedure | Number of mortalities will be reported. |
| Length of Hospital Stay | Intraoperative, Up to 30 days post-procedure | The length of hospital stay from the date of procedure until discharge will be reported. |
| Total Operative Time | Intraoperative | Total procedure time is defined by the time taken for the procedure, that is, from skin incision to skin closure. |
Countries
United States
Contacts
CONTACTDamaris Pederson, MPH
CONTACTDominic Papandria, MD
STUDY_DIRECTORAuris Health, Inc. Clinical Trial
Auris Health, Inc.
Outcome results
None listed