Anastomotic Leak RectumORSYNCT05174910
Investigation of the Benefit of Using an Autologous Platelet-rich Fibrin Matrix (Obsidian ASG®) for Treatment of Anastomosis During Rectal Surgery
A study testing Obsidian ASG in people with Anastomotic Leak Rectum, run by Vivostat at 13 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anastomotic Leak Rectum
- What is being tested?
- Obsidian ASG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 13 sitesin 5 countries
- Study dates
- 23 Dec 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
13 sites in 5 countries.
13 sites in 5 countries
Germany5 sites
Universität Augsburg
Augsburg, 86152
Diakonissenkrankenhaus Dresden
Dresden, 01099
Klinikum Fürth
Fürth, 90766
Klinikum Nürnberg Nord
Nuremberg, 90419
RoMed Klinikum Rosenheim
Rosenheim, Bavaria, 83022
Austria4 sites
Krankenhaus der Barmherzigen Brûder
Graz, 8020
Kepler Universitätsklinikum GmbH, Med campus III
Linz, 4021
Krankenhaus der Barmherzigen Brüder Wien
Vienna, 4041
Landesklinikum Wienerneustadt
Wiener Neustadt, 2700
Spain2 sites
Granada Hospital
Granada, 18016
Consorci Hospital General Universitari de Valencia
Valencia, 46016
About this study
Official title: 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
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 2x125 patients
Read more
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.
- Conditions
- Anastomotic Leak Rectum
- Being tested
- Obsidian ASG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obsidian ASGDevice
Application of an autologous platelet-rich fibrin matrix
| Study group | Role | What they receive |
|---|---|---|
| With Obsidian ASG | Active comparator | Anastomosis treatment using standard procedure and Obsidian ASG Receives: Device: Obsidian ASG |
| Without Obsidian ASG | No intervention | Anastomosis treatment using standard procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomosis insufficiency [yes/no]
Anastomosis insufficiency after colorectal surgery with primary anastomosis
Measured: 45 days
Secondary outcomes (3)
Anastomotic insufficiency [0/A/B/C]*
*ISREC, International Study Group of Rectal Cancer - severity grading of anastomotic leakage
Measured: 45 days
Staple suture line bleeding requiring surgical intervention [yes, with surgical intervention / yes, without surgical intervention / no]
Staple suture line bleeding requiring surgical intervention
Measured: 45 days
Postoperative hospital length of stay [days]
Days spent in hospital after undergoing colorectal surgery
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2022
- Study start23 Dec 2021
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anastomotic Leak RectumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, prospective, randomized, single-blind
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vivostat
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Raffeiner GmbH, European Commission, AF Schimetta GMbH, Rivolution GmbH
- Responsible party
- Sponsor
- Investigators
- Andreas Shamiyeh, Prim.Doz.Dr., Principal investigator, Kepler Universitätsklinikum Gmbh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174910
- Sponsor's protocol ID
- ORSY
- Acronym
- ORSY
- Status last verified
- Jul 2024
- First submitted
- 30 Nov 2021
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05174910
- Acronym / sponsor ID
- ORSY / ORSY
- Conditions
- Anastomotic Leak Rectum
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- VivostatIndustry (pharma, biotech, devices)
- Collaborators
- Raffeiner GmbH, European Commission, AF Schimetta GMbH, Rivolution GmbH
- Study start
- 23 Dec 2021 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 3 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 2x125 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Multicenter, prospective, randomized, single-blind
| Arm | Type | Receives |
|---|---|---|
| With Obsidian ASG | Active comparator | Device: Obsidian ASGAnastomosis treatment using standard procedure and Obsidian ASG |
| Without Obsidian ASG | No intervention | –Anastomosis treatment using standard procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Obsidian ASGApplication of an autologous platelet-rich fibrin matrix | Device | With Obsidian ASG |
Primary outcome
Anastomosis insufficiency [yes/no]
Time frame: 45 days
Anastomosis insufficiency after colorectal surgery with primary anastomosis
3 secondary outcomes
Anastomotic insufficiency [0/A/B/C]*
Time frame: 45 days
Staple suture line bleeding requiring surgical intervention [yes, with surgical intervention / yes, without surgical intervention / no]
Time frame: 45 days
Postoperative hospital length of stay [days]
Time frame: 45 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Anastomotic Leak Rectum
Not yet recruiting
FLuorescent Angiography in REduction of Anastomotic Leak in Rectal Cancer Surgery
Rectal Cancer Patients, Rectal Cancer Surgery
Not yet recruiting
Betacyanin for Early Diagnosis and Recovery of Anastomotic Leakage After Rectal Cancer Surgery: A Single-Center, Prospective, Controlled Trial
Rectum Cancer, Anastomotic Leak
RecruitingPhase 4
SIS-Reinforced vs. Conventional Anastomosis for Mid-to-Low Rectal Cancer: A Multicenter RCT on Anastomotic Leak
Rectal Cancer
RecruitingObservational study
Endoscopic COlorectal Mucosal Evaluation of Oxygen Tension
Anastomotic Leak Rectum, Anastomotic Leak Large Intestine
Not yet recruiting
VACStent Use for the Treatment of Anastomotic Leakage Following coloREctal Surgery
Colorectal Surgery, Anastomotic Leak Rectum
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Shamiyeh, Prim.Doz.Dr. principal investigator
Kepler Universitätsklinikum Gmbh
13 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Obsidian ASG in people with Anastomotic Leak Rectum, run by Vivostat at 13 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Germany, Austria, Spain, Italy, Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anastomosis insufficiency [yes/no] (time frame: 45 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.