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Investigation of the Benefit of Using an Autologous Platelet-rich Fibrin Matrix (Obsidian ASG®) for Treatment of Anastomosis During Rectal Surgery (ORSY)

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ClinicalTrials.gov Identifier: NCT05174910
Recruitment Status : Recruiting
First Posted : January 3, 2022
Last Update Posted : May 12, 2023
Sponsor:
Collaborators:
Raffeiner GmbH
AF Schimetta GMbH
Rivolution GmbH
European Commission
Information provided by (Responsible Party):
Vivostat

Tracking Information
First Submitted Date  ICMJE November 30, 2021
First Posted Date  ICMJE January 3, 2022
Last Update Posted Date May 12, 2023
Actual Study Start Date  ICMJE December 23, 2021
Estimated Primary Completion Date October 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2021)		 Anastomosis insufficiency [yes/no] [ Time Frame: 45 days ]
Anastomosis insufficiency after colorectal surgery with primary anastomosis
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2021)
  • Anastomotic insufficiency [0/A/B/C]* [ Time Frame: 45 days ]
    *ISREC, International Study Group of Rectal Cancer - severity grading of anastomotic leakage
  • Staple suture line bleeding requiring surgical intervention [yes, with surgical intervention / yes, without surgical intervention / no] [ Time Frame: 45 days ]
    Staple suture line bleeding requiring surgical intervention
  • Postoperative hospital length of stay [days] [ Time Frame: 45 days ]
    Days spent in hospital after undergoing colorectal surgery
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigation of the Benefit of Using an Autologous Platelet-rich Fibrin Matrix (Obsidian ASG®) for Treatment of Anastomosis During Rectal Surgery
Official Title  ICMJE Investigation of the Benefit of Using an Autologous Platelet-rich Fibrin Matrix (Obsidian ASG®) for Treatment of Anastomosis During Rectal Surgery - a Single-blind, Randomized, Multicenter Pilot Study
Brief Summary

Anastomotic insufficiency remains one of the most significant problems after rectal resection.The complications following anastomotic insufficiency leads to increased morbidity and mortality with subsequent prolongation of hospital stay and higher costs.

This study is an investigation of the benefit of using an autologous platelet-rich fibrin matrix (Obsidian ASG®) for treatment of anastomosis during rectal surgery - a single-blind, randomized, multicenter pilot study with enrollment of 2x220 patients

The main objective of the study is to investigate on an exploratory basis whether the use of Obsidian ASG® during rectal resection reduces the frequency of postoperative anastomotic insufficiency compared to standard anastomotic technique.

The secondary objectives of the study are to investigate on an exploratory basis:

  • The frequency of anastomotic insufficiency (ISREC Criteria) severity
  • Staple line bleeding requiring surgical intervention
  • The duration of postoperative hospitalization are reduced when using Obsidian ASG ® compared with standard anastomotic treatment alone.

are reduced when Obsidian ASG ® is added to the standard of anastomotic treatment compared with standard anastomotic treatment alone.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Multicenter, prospective, randomized, single-blind
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Anastomotic Leak Rectum
Intervention  ICMJE Device: Obsidian ASG
Application of an autologous platelet-rich fibrin matrix
Study Arms  ICMJE
  • Active Comparator: With Obsidian ASG
    Anastomosis treatment using standard procedure and Obsidian ASG
    Intervention: Device: Obsidian ASG
  • No Intervention: Without Obsidian ASG
    Anastomosis treatment using standard procedure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 13, 2021)		 440
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date October 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

The following inclusion criteria will be considered:

  • Written informed consent
  • Age > 18 years
  • Indication for elective oncological rectal resection in the presence of malignant rectal disease and the lower edge of the tumor, measured from the anal verge with the rigid rectoscope, ≤ 14cm
  • Use of a circular anastomosis using the "double stapling technique"(6) during creation of the anastomosis
  • Expected availability within the maximum 45-day period of study participation
  • The use of "golden standard" stapling technology devices; 3 rows endo linear stapler; 2 rows circular stapling devices should be used in an open and laparoscopic approach

Exclusion Criteria:

The following exclusion criteria will be considered:

  • Pregnancy, or the non-exclusion of pregnancy (for women of childbearing potential). In the case of menopause having occurred more than 2 years ago or postmenopausal sterilization or surgical sterilization, the authorized physician is free to classify the female study participant as non-pregnant, so that the pregnancy test otherwise required at the beginning of study participation (or during subject screening) may be omitted.
  • Risk of pregnancy occurring while taking part in the study in women not meeting at least one of the following criteria: Onset of menopause more than 2 years ago, postmenopausal sterilization, surgical sterilization, a promise to use contraception (with hormones, coil or diaphragm/condom + spermicide), while enrolled in the study) In the case of onset of menopause more than 2 years ago, postmenopausal sterilization or surgical sterilization, the authorized doctor is free to classify the patient in question as infertile. Furthermore, it is at the discretion of the authorized physician to classify the patient in question on the basis of continuous inpatient care in such a way that the occurrence of pregnancy during participation in the study can be ruled out ("continuous determination of the absence of pregnancy"). If one of the above classifications applies, further measures to ensure that a pregnancy does not occur during the patient's participation in the study may not be required.
  • Breastfeeding period
  • Lack of legal capacity
  • Vulnerable persons according to the law
  • Comorbidity with the potential for relevant impairment of anastomosis durability (leukemia, cirrhosis of the liver, Child Pugh C, etc.)
  • Preoperative anemia with Hb <8g/dL
  • Participating in another study
  • Patients on Aspirin not able to stop using Aspirin for medical reasons minimum 3 days before taking the blood sampling.
  • Patients on Clopidogrel not able to stop using Clopidogrel for medical reasons minimum 7 days before blood sampling.
  • Patients on other platelet aggregation inhibitor therapies
  • Contraindication for Obsidian ASG®
  • Surgical technique of transanal total mesorectal excision (TaTME)
  • Application of a circular powered stapler in the course of anastomosis supply with GSTTM technology or a 3 row circular stapler use while creating the study anastomosis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Peter S Nielsen, MSc +4561728995 psn@vivostat.com
Contact: Sven Lange, MSc +4560108868 sla@vivostat.com
Listed Location Countries  ICMJE Austria,   Belgium,   Denmark,   Germany,   Italy,   Serbia,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05174910
Other Study ID Numbers  ICMJE ORSY
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Vivostat
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Vivostat
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Raffeiner GmbH
  • AF Schimetta GMbH
  • Rivolution GmbH
  • European Commission
Investigators  ICMJE
Principal Investigator: Andreas Shamiyeh, Prim.Doz.Dr. Kepler Universitätsklinikum Gmbh
PRS Account Vivostat
Verification Date May 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP