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Quantifying the Effect of the Crane Technique Through Three-dimensional Imaging

NCT ID: NCT04418583

Last Updated: 2020-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-13

Study Completion Date

2021-03-31

Brief Summary

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Pectus excavatum is the most common congenital abnormality of the thoracic wall and occurs in 1 in 400 newborns. The gold standard treatment is the Nuss bar Procedure. However, in very severe cases, pectus exacavatum involves little or no space between the heart and sternum. Because of the limited space, the Nuss procedure is more difficult to perform and there is an increased risk of complications such as injuries to the heart or large vessels. However, this increased risk can again be reduced by using the Crane technique. This technique increases the substernal space by sternal 'hoisting' via an external steel wire. Despite the fact that this technique is commonly used, it is not known what its quantitative effect is on the substernal space during the Nuss bar procedure. The subsequent aim of this study is to quantify the effect of the Crane technique during minimally invasive repair of pectus excavatum through three-dimensional scans acquired before and after application of the Crane technique.

Detailed Description

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Conditions

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Pectus Excavatum Funnel Chest

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective case-control study wherein participants are their own control
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Three-dimensional imaging

Participants receive a three-dimensional image of their chest, just prior to and after application of the Crane technique.

Group Type EXPERIMENTAL

Three-dimensional imaging

Intervention Type DIAGNOSTIC_TEST

Three-dimensional surface images, acquired by the Artec Leo

Interventions

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Three-dimensional imaging

Three-dimensional surface images, acquired by the Artec Leo

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Undergoing minimally invasive repair of pectus excavatum (through the Nuss bar procedure) in conjunction with the Crane technique.

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zuyderland Medisch Centrum

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Zuyderland Medical Centre

Heerlen, Limburg, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Facility Contacts

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Jean Daemen

Role: primary

[email protected]
+314597777

Other Identifiers

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METCZ20200071

Identifier Type: -

Identifier Source: org_study_id