Recruiting

AirSeal

Sponsor:

Weill Medical College of Cornell University

Code:

NCT07710352

Conditions

Robotic Surgery

Pneumoperitoneum

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AirSeal Robotic Solution

Standard-pressure pneumoperitoneum (15 mmHg)

Study Details

Brief summary:

During surgery that is done using a robot, the surgeon needs to put carbon dioxide gas into the belly to lift the belly wall. This is done so the surgeon can adequately see all the body organs and operate safely. Many surgeons currently use a standard pressure of 15 mmHg (a unit to measure pressure). However, many patients find the use of this pressure to be painful after surgery. New research has shown that using a lower pressure with a device called "AirSeal" can safely reduce pain and lead to faster recovery after surgery.

The goal of this clinical trial is to learn if using a lower gas pressure with the AirSeal device during robotic surgery, compared to standard gas pressure with conventional devices, helps adults feel less pain and recover faster.

The study includes adults aged 18 or older having robotic at New York-Presbyterian Hospital/Weill Cornell Medical Center.

The main questions this clinical trial aims to answer are:

1. Does using lower gas pressure shorten the time people spend in the recovery room after surgery?
2. Does using lower gas pressure lead to less pain and reduce the need for pain medicine after surgery?

Conditions

Robotic Surgery

Pneumoperitoneum

Study ID

NCT07710352

Start date

Jul 30, 2026

Status verified date

Aug, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Aged 18 years or older
  • Scheduled to undergo robotic-assisted surgery at New York-Presbyterian/Weill Cornell Medical Center
  • American Society of Anesthesiologists physical status I-III
  • Able to understand and provide written informed consent in English

Exclusion Criteria:

  • American Society of Anesthesiologists physical status IV or higher (i.e. a severe systemic disease that is a constant threat to life such as decompensated heart failure)
  • Chronic opioid use (≥30 morphine milligram equivalents per day for ≥30 days within the past 6 months)
  • Current pregnancy
  • Inability to understand and provide informed consent in English
  • Inability to provide informed consent due to cognitive impairment or other conditions impacting decision-making capacity
  • Scheduled open or laparoscopic surgeries

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Low-pressure pneumoperitoneum (AirSeal)

Participants who are assigned to this arm will receive 8 mmHg pneumoperitoneum using the AirSeal Robotic Solution device.

The AirSeal Robotic Solution device is a FDA 510(k)-cleared carbon dioxide insufflation platform with valveless trocar technology that helps to maintain stable intra-abdominal pressure during surgery.

active comparator: Standard-pressure pneumoperitoneum

Participants who are assigned to this arm will receive 15 mmHg pneumoperitoneum using the conventional insufflation machine at New York-Presbyterian/Weill Cornell Medical Center.

Interventions

AirSeal Robotic Solution

The experimental intervention is low-pressure pneumoperitoneum at 8 mmHg using the AirSeal Robotic Solution device.

The AirSeal Robotic Solution (CONMED Corporation) is an FDA 510(k)-cleared carbon dioxide insufflation device that is indicated for use in robotic-assisted surgery. It consists of a console, tri-lumen filtered tube set, and access ports that function as valveless trocars.

The console of the device is mounted on a cart and regulates carbon dioxide flow and smoke evacuation by continuously measuring the intra-abdominal pressure. The trilumen filtered tube set carries carbon dioxide to the abdomen, transmits pressure information back to the console, and returns gas from the abdomen for smoke evacuation and filtration. These features allow for the device to operate in the "AirSeal" mode, whereby the pressure within the abdomen is effectively kept constant. The valveless trocars are access ports for the minimally invasive tools to enter the abdominal cavity.

Standard-pressure pneumoperitoneum (15 mmHg)

The control intervention is standard-pressure pneumoperitoneum set at a pressure of 15 mmHg. This will be delivered using the operating room's conventional valved-trocar carbon dioxide insufflator.

Primary outcome measure

  • Average post-anesthesia care unit (PACU) length of stay in minutes from PACU admission to PACU discharge order [ Time Frame: From PACU arrival (5 minutes post-surgery) to PACU discharge-order (1 to 4 hours post-surgery) ]

Central Contacts and Locations

Central contacts

Cheguevara Afaneh, MD

(646) 962-8462cha9043@med.cornell.edu

Locations

New York-Presbyterian/Weill Cornell Medical Center GI Metabolic and Bariatric Surgery

Recruiting

New York, New York, United States, 10021

Contacts

Cheguevara Afaneh, MD

(646) 962-8462cha9043@med.cornell.edu

Principal Investigator:

Cheguevara Afaneh, MD

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

  • robotic surgery
  • low-pressure pneumoperitoneum
  • recovery time
  • pain
  • pneumoperitoneum

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-08-20.