CAIman 5 Articulating Maryland in coloRECTAL Cancer Surgery | NCT04175756

Studies
CAIman 5 Articulating Maryland in coloRECTAL Cancer Surgery

NCT04175756

Sponsor

Aesculap AG

Status

Completed

Last Update Posted

Jul 15, 2021Actual

Enrollment

61Actual

Phase

Not provided

Conditions

Colorectal Cancer

Interventions

Caiman 5 articulating Maryland

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2, 2020Actual

Primary Completion Date

Jan 10, 2021Actual

Completion Date

Apr 28, 2021Actual

First Submitted Date

Nov 19, 2019

First Submission Date that Met QC Criteria

Nov 21, 2019

First Posted Date

Nov 25, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 14, 2021

Last Update Posted Date

Jul 15, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

61Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Caiman 5 articulating Maryland	Device	Laparoscopic colorectal surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total operative time	Time between first incision and closure of the surgical incision	intraoperatively

Secondary Outcomes

Measure	Description	Time Frame
Complications	Number of Complications: Wound infections, Urinary tract infections, Pulmonary infections, Other infections, Wound dehiscence, Anastomotic leak, Anastomotic bleeding, Other bleeding / hemorrhage, Intraabdominal abscess, Fistula, Peritonitis, Sepsis, Hernia, Stenosis Ileus, Ureter injury, Nerve injury, Cardiac complications, Other	up to 4 months postoperative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

adult patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Niedergethmann, Prof. Dr. med.	Alfried Krupp Krankenhaus, 45131 Essen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alfried Krupp Krankenhaus Rüttenscheid		Essen		45131	Germany

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided