NCT05613959

Brief Summary

18 participants (novices, intermediates and experts) performed in total 248 insertions in a systematic way on Thiel embalmed bodies with wide and small bore versions of the conventional VNc (conventional Veress Needle) and the VN+(The Veress Needle plus). Insertion depth was measured by recording the graduations on the needle under direct laparoscopic vision.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

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

Study Start

First participant enrolled

January 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

November 14, 2022

Completed
Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

9 months

First QC Date

October 17, 2022

Last Update Submit

November 8, 2022

Conditions

Pneumoperitoneum

Keywords

Veress NeedleThiel Embalmed CadaversLaparoscopySafety mechanism

Outcome Measures

Primary Outcomes (1)

  • depth of insertion

    the depth of insertion of the needle into the abdominal cavity

    20 minutes

Study Arms (2)

Veress +

The Veress+ system was used

Device: Veress +

Veress conventional

The Conventional Veress needle was used

Device: Conventional Veress

Interventions

Veress +DEVICE

The Veress+ safety mechanism was used

Veress +
Conventional VeressDEVICE

The Conventional Veress Needle was used

Veress conventional

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Surgical residents, young surgeons, exeprienced surgeons from the University of Malta Mater Dei Hospital

You may qualify if:

  • medical background, healthy

You may not qualify if:

  • physically or mentally handicapped

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory for Anatomy

Valletta, MSD 2080, Malta

Location

MeSH Terms

Conditions

Pneumoperitoneum

Condition Hierarchy (Ancestors)

Peritoneal DiseasesDigestive System Diseases

Study Officials

  • Jean Calleja Agius, MD PhD

    University of Malta

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor; Head of Department of Anatomy

Study Record Dates

First Submitted

October 17, 2022

First Posted

November 14, 2022

Study Start

January 1, 2021

Primary Completion

September 26, 2021

Study Completion

September 26, 2021

Last Updated

November 14, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

MA(1)