NCT02262039

Brief Summary

The purpose of this study is to determine if the Airseal System will reduce post-operative pain and reduce the need for narcotics in laparoscopic living kidney donor surgeries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable pain

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

July 9, 2014

Completed
23 days until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 10, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
11 months until next milestone

Results Posted

Study results publicly available

December 23, 2016

Completed
Last Updated

January 17, 2018

Status Verified

January 1, 2018

Enrollment Period

1.3 years

First QC Date

July 9, 2014

Results QC Date

September 8, 2016

Last Update Submit

January 12, 2018

Conditions

Pain

Keywords

livingkidneydonors

Outcome Measures

Primary Outcomes (3)

  • Narcotic Use (mg)

    Total Morphine Equivalents - mean in mg

    Intra-Operative on day of surgery

  • Narcotic Use (mg)

    Total Morphine Equivalents - mean in mg

    Post-operative (until time of discharge, typically 2-4 days)

  • Narcotic Use (mg)

    Total Morphine Equivalent - mean in mg

    Operative and Post-operative (until time of discharge, typically 2-4 days)

Secondary Outcomes (4)

  • Subjective Pain Score

    1 hour post-op

  • Subjective Pain Score

    6 hours post-op

  • Subjective Pain Score

    12 hours post-op

  • Mean ETCO2

    intraoperative

Study Arms (2)

Conventional Pressure

ACTIVE COMPARATOR

Conventional Insufflation with 15mmHg target pressure

Device: Conventional pressure

Low Pressure (VTI)

EXPERIMENTAL

Valveless recirculating insufflation (VTI) with 10mmHg target pressure

Device: Valveless recirculating insufflation (VTI)

Interventions

Valveless recirculating insufflation (VTI)DEVICE

10 mmHg target pressure

Low Pressure (VTI)
Conventional pressureDEVICE

15 mmHg target pressure

Conventional Pressure

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Any living donor who has been approved to donate a kidney is eligible to participate.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale New Haven Transplantation Center

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Sanjay Kulkarni
Organization
Yale University
sanjay.kulkarni@yale.edu
203-785-6501

Study Officials

  • Sanjay Kulkarni, MD

    Yale University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

July 9, 2014

First Posted

October 10, 2014

Study Start

August 1, 2014

Primary Completion

December 1, 2015

Study Completion

February 1, 2016

Last Updated

January 17, 2018

Results First Posted

December 23, 2016

Record last verified: 2018-01

Locations

US(1)