LifeSeal™ Pilot Study in Subjects Undergoing Circular Stapled Anastomosis Created Within 10 cm of the Anal Verge

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

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-08-31

Brief Summary

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

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Detailed Description

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Conditions

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Rectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control arm - Standard of Care

The anastomosis will be created using Standard of Care only

Group Type NO_INTERVENTION

No interventions assigned to this group

Device arm - Standard of Care + LifeSeal™ Kit

The anastomosis will be created using SOC + LifeSeal™ Kit

Group Type EXPERIMENTAL

LifeSeal™ Kit

Intervention Type DEVICE

Interventions

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LifeSeal™ Kit

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No