LifeSeal™ Preliminary Study in Subjects Undergoing Low Anterior Resection

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01790230

Enrollment

Registered

2013-02-13

Start date

2013-01-31

Completion date

2013-08-31

Last updated

2013-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

Brief summary

A preliminary Study in Subjects Undergoing Low Anterior Resection

Interventions

DEVICELifeSeal™ Kit

Application of LifeSeal™ Kit for staple line reinforcement during open GI surgeries in Low Anterior Resection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Assessment of subject's safety by incidence of related Adverse Events	Approx. 1 month

Secondary

Measure	Time frame	Description
Assessment of the device's application technique	Intra-operative	Surgeon will complete a questionnaire regarding the device use and ease of application

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026