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

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02046278
• Other study ID #: CLP-LS-0110
• Status: Completed
• Phase: N/A
• First received: January 23, 2014
• Last updated: August 29, 2016
• Start date: January 2014
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: LifeBond Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHPSweden: Medical Products AgencyIsrael: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 2016
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Device:
• LifeSeal™ Kit

Locations

Country	Name	City	State
Belgium	OLV Ziekenhuis	Aalst
Belgium	Ziekenhuis Oost-Limburg	Genk
Belgium	University Hospital	Gent
Belgium	UZ Leuven	Leuven
Israel	Sourasky Medical Center	Tel Aviv
Sweden	Skane University Hospital	Malmo
Sweden	Karolinska Institutet	Stockholm
Sweden	Uppsala University Hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
LifeBond Ltd.

Countries where clinical trial is conducted

Belgium,  Israel,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the overall Subject safety by incidence of pre specified procedure related Adverse Events.		Up to 15 weeks	Yes
Secondary	Performance Rate of anastomotic leak (both radiological and clinical leaks)		Up to 15 weeks post procedure or at stoma closure, whichever comes first	Yes