NCT02046278

Brief Summary

A Pilot Study in Subjects Undergoing circular stapled anastomosis created within 10 cm of the anal verge.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
3 countries

8 active sites

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, 2014

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 27, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 30, 2016

Status Verified

August 1, 2016

Enrollment Period

7 months

First QC Date

January 23, 2014

Last Update Submit

August 29, 2016

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Assessment of the overall Subject safety by incidence of pre specified procedure related Adverse Events.

    Up to 15 weeks

Secondary Outcomes (1)

  • Performance Rate of anastomotic leak (both radiological and clinical leaks)

    Up to 15 weeks post procedure or at stoma closure, whichever comes first

Study Arms (2)

Control arm - Standard of Care

NO INTERVENTION

The anastomosis will be created using Standard of Care only

Device arm - Standard of Care + LifeSeal™ Kit

EXPERIMENTAL

The anastomosis will be created using SOC + LifeSeal™ Kit

Device: LifeSeal™ Kit

Interventions

LifeSeal™ KitDEVICE
Device arm - Standard of Care + LifeSeal™ Kit

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject, or authorized representative, signed a written Informed Consent Form
  • Subject is 18 years or older
  • Subject is scheduled for elective open or laparoscopic surgery involving the creation of a circular stapled anastomosis created within 10cm from the anal verge.
  • If female - not be of child bearing potential, or be using acceptable contraception methods.
  • Subject participating in studies involving approved drug or device will be enrolled only following a mutual consideration of the investigator together with the Sponsor.

You may not qualify if:

  • Subject has a history of hypersensitivity to porcine derived gelatin or collagen
  • Subject participating in any other study involving an investigational (unapproved) drug or device.
  • Subject with a BMI higher than 40
  • Female Subject states that she is pregnant or breast feeding
  • Subject with ASA status higher than 3
  • Avastin use within 30 days prior to surgery
  • Subject who underwent a prior pelvic anastomosis
  • Subject is scheduled for another surgery during the follow up period of this study (not including stoma closure)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

OLV Ziekenhuis

Aalst, Belgium

Location

Ziekenhuis Oost-Limburg

Genk, Belgium

Location

University Hospital

Ghent, Belgium

Location

UZ Leuven

Leuven, Belgium

Location

Sourasky Medical Center

Tel Aviv, Israel

Location

Skane University Hospital

Malmo, Sweden

Location

Karolinska Institutet

Stockholm, Sweden

Location

Uppsala University Hospital

Uppsala, SE-751 85, Sweden

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2014

First Posted

January 27, 2014

Study Start

January 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2016

Last Updated

August 30, 2016

Record last verified: 2016-08

Locations

IL(1)BE(4)SE(3)