NCT02114164

Brief Summary

The AirSeal® System will allow for lower carbon dioxide (CO2) absorption rates than the standard Endopath System.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 15, 2014

Completed
2.3 years until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2019

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

November 26, 2021

Completed
Last Updated

November 26, 2021

Status Verified

October 1, 2021

Enrollment Period

1.8 years

First QC Date

January 10, 2014

Results QC Date

September 10, 2021

Last Update Submit

October 28, 2021

Conditions

Prostate CancerPneumoperitoneum

Keywords

AirSealTrocarCarbon Dioxide Exchange and Absorption

Outcome Measures

Primary Outcomes (1)

  • Intraoperative Pneumoperitoneal Pressure (mmHg)

    Pneumoperitoneal pressure is the pressure exerted by air or gas in the abdominal (peritoneal) cavity. As the amount of air/gas increases, the pressure (mmHg) increases. The highest pressure that occurred during the procedure was compared between groups.

    Through end of procedure, an average of 156 minutes

Secondary Outcomes (7)

  • Intraoperative Arterial Blood Gas Carbon Dioxide (mmHg).

    Baseline, 60 minutes, and at end of procedure, an average of 156 minutes

  • End-tidal Carbon Dioxide Pressure (mmHg)

    Baseline, 60 minutes, and at end of procedure, an average of 156 minutes

  • Carbon Dioxide Elimination (mmHg)

    Baseline, 60 minutes, and at end of procedure, an average of 156 minutes

  • Intraoperative Arterial Blood Gas Oxygen (mmHg).

    Baseline, 60 minutes, and end of procedure, an average of 156 minutes

  • Number of Ventilator Interventions

    Through end of procedure, an average of 156 minutes

  • +2 more secondary outcomes

Study Arms (2)

AirSeal System

ACTIVE COMPARATOR

This group receives the AirSeal System for intraoperative insufflation.

Device: AirSeal System

Standard Endopath

ACTIVE COMPARATOR

This group receives the Standard Endopath Trocar for intraoperative insufflation.

Device: Standard Endopath

Interventions

AirSeal SystemDEVICE

To analyze the results of patients randomized to either the AirSeal system or Standard Endopath trocar.

Also known as: Valve-free Trocar
AirSeal System
Standard EndopathDEVICE

This group receives the Standard Endopath Trocar for intraoperative insufflation.

Also known as: Endopath Trocar
Standard Endopath

Eligibility Criteria

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

You may qualify if:

  • Age\>18
  • Eligible and elect to undergo robotic prostatectomy surgery @ OhioHealth Dublin Methodist Hospital

You may not qualify if:

  • Age \< 18
  • Emergency surgery
  • Ascites
  • BMI\>44 or \<18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dublin Methodist Hospital

Columbus, Ohio, 43016, United States

Location

Related Publications (1)

  • Abaza R, Martinez O, Murphy C. Randomized Controlled Comparison of Valveless Trocar (AirSeal) vs Standard Insufflator with Ultralow Pneuomoperitoneum During Robotic Prostatectomy. J Endourol. 2021 Jul;35(7):1020-1024. doi: 10.1089/end.2020.1025. Epub 2021 Jan 21.

    PMID: 33349135DERIVED

MeSH Terms

Conditions

Prostatic NeoplasmsPneumoperitoneum

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesPeritoneal DiseasesDigestive System Diseases

Results Point of Contact

Title
Dr. Oscar Martinez
Organization
OhioHealth
oscar.martinez@ohiohealth.com
(614) 544-8104

Study Officials

  • Ronney Abaza, MD,FACS

    OhioHealth

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2014

First Posted

April 15, 2014

Study Start

August 1, 2016

Primary Completion

May 3, 2018

Study Completion

July 15, 2019

Last Updated

November 26, 2021

Results First Posted

November 26, 2021

Record last verified: 2021-10

Locations

US(1)