CAIman 5 Articulating Maryland in coloRECTAL Cancer Surgery

NCT ID: NCT04175756

Last Updated: 2021-07-15

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

COMPLETED

Total Enrollment

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-02

Study Completion Date

2021-04-28

Brief Summary

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This voluntary study is part of a Post-Market-Surveillance plan to proactively collect clinical data for the use of Caiman 5 articulating Maryland in colorectal surgery under daily clinical routine.

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Caiman 5 articulating Maryland

Laparoscopic colorectal surgery

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient´s written informed consent
* Planned laparoscopic colorectal cancer surgery using Caiman 5 articulating Maryland (according to the IfU)
* Age ≥18 years

Exclusion Criteria

* Emergency surgery
* Pregnancy
* Participation in another surgical study, which might influence the intraoperative process
* Conversion to open surgery
* Conversion to another sealing / cutting instrument (instead of Caiman 5 articulating Maryland)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aesculap AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Niedergethmann, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Alfried Krupp Krankenhaus, 45131 Essen

Locations

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Alfried Krupp Krankenhaus Rüttenscheid

Essen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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AAG-O-H-1627

Identifier Type: -

Identifier Source: org_study_id

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