LifeSeal™ Preliminary Study in Subjects Undergoing Low Anterior Resection

L

LifeBond

Status

Completed

Conditions

Rectal Cancer

Treatments

Device: LifeSeal™ Kit

Study type

Interventional

Funder types

Industry

Identifiers

NCT01790230
CLP-LS-0105

Details and patient eligibility

About

A preliminary Study in Subjects Undergoing Low Anterior Resection

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Subject, or authorized representative, signed a written Informed Consent
  2. Subject is at least 18 years of age
  3. Subject is scheduled for elective open resection
  4. Stapled anastomosis created within 10cm of the anal verge
  5. Subject is willing to comply with the follow-up requirements of the study

Exclusion criteria

  1. Subject has a history of hypersensitivity to porcine derived gelatin or collagen
  2. Subject has unacceptable baseline hematological results
  3. Subject on chronic preoperative treatment with steroids and anticoagulants
  4. Subject with elevated liver function tests
  5. Subject with abnormal kidney function
  6. Subject with a BMI higher than 35
  7. Subject participating in any other study for either drug or device which can influence collection of valid data under this study
  8. Subject with a history of MI, CVA or ASA status IV or a life expectancy of less than 1 year
  9. Anastomosis was performed differently from what was defined
  10. Subject received intraoperative sealant, glue or any buttressing material for the study related anastomosis, other than the LifeSeal™
  11. Subject has intraoperative bleeding in excess of 500cc
  12. Subject has peritoneal carcinomatosis

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

10 participants in 2 patient groups

Standard of Care
No Intervention group
Description:
Standard of Care Arm - subjects treated by routine manner
LifeSeal™ Kit
Experimental group
Description:
LifeSeal™ Kit Arm - subjects treated with the LifeSeal™ Kit device + Standard of Care treatment
Treatment:
Device: LifeSeal™ Kit

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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