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Anastomotic Leak EsophagusPhase 2Obsidian ph IINCT05713955

OBSiDiAN in a Stapled Circular Esophagogastric Anastomosis After Ivor Lewis Esophagectomy

A Phase 2 study testing Obsidian in people with Anastomotic Leak Esophagus, run by University Hospital, Ghent at 2 sites in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Oesophagectomy is very invasive surgery. A leakage at the level of the connection between oesophagus and stomach made during surgery causes a lot more problems and can lead to death. Studies show that the leakage rate sometimes goes up to 40 per cent. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Anastomotic Leak Esophagus
What is being tested?
Obsidian
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
2 sitesBelgium
Study dates
1 Jun 2025to 1 Jan 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult
  1. Inclusion criteria Preoperatively
  • Subjects ≥ 18 years and ≤ 75 years who are willing to participate and provide written informed consent prior to any study-related procedures.
  • Subjects with esophageal carcinoma (distal until Siewert II) scheduled for elective minimally invasive Ivor Lewis esophagectomy (cT1-4a,N0-3,M0). Intra-operatively
  • Intrathoracic circular stapled esophagogastric anastomosis
  1. Exclusion criteria preoperatively
  • Female patients who are pregnant or nursing
  • Participation in another study involving investigational drugs or devices.
  • Use of Avastin within 30 days prior to surgery
  • ASA IV (patient with severe systemic disease that is a constant threat to life)
  • Patients with other malignancies
  • Patients with previous esophageal or gastric surgery
  • Known hypersensitivity to batroxobin and tranexamic acid.
  • HB level < 8 g/dL
  • Patients on medicine containing acetylsalicylic acid not able to stop using the medicine for medical reasons minimum 3 days before taking the blood sampling.
  • Patients on clopidogrel not able to stop clopidogrel for medical reasons 7 days before blood sampling
  • Patients on other platelet aggregation inhibitor therapies not able to stop using the platelet aggregation inhibitor therapies for 3 days before taking the blood sample.

Intra-operatively

  • Intra-operative findings that may preclude conduct of the study procedures, such as pleural metastasis, tumor invasion in other organs, …
  • Anastomosis preformed differently than the standard of care
  • Excessive bleeding (>500 ml) prior to anastomosis

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Hanne Vanommeslaeghe contact

+3293325945

hanne.vanommeslaeghe@uzgent.be

Belgium2 sites, 2 recruiting

  • University Hospital Ghent

    Ghent, East-Flanders, 9000

    Hanne Vanommeslaeghe, MD, 00323325945, hanne.vanommeslaeghe@uzgent.be

    Not yet recruiting

  • University Hospital Ghent

    Ghent, East-Flanders, 9000

    Hanne Vanommeslaeghe, MD, 00323325945, hanne.vanommeslaeghe@uzgent.be

    Recruiting

Other trials in Belgium

About this study

Official title: Evaluation of Effectiveness and Safety of Autologous BioMatrix OBSiDiAN to Enhance a Stapled Circular Esophagogastric Anastomosis After Ivor Lewis Esophagectomy, a Phase II Study.

Oesophagectomy is very invasive surgery. A leakage at the level of the connection between oesophagus and stomach made during surgery causes a lot more problems and can lead to death. Studies show that the leakage rate sometimes goes up to 40 per cent. The chance of dying if you develop a leak after surgery is 15%, while the overall chance of dying during hospitalisation for this procedure is about 4%. We want to investigate whether the use of this new type of 'glue' (Obsidian®) can reduce the number of leaks. We invite you to participate in a clinical trial with the aim of investigating whether Obsidian® is safe and can reduce the number of leaks after oesophageal surgery in patients with oesophageal cancer. We want to apply a new type of 'glue', Obsidian®, at the level of the new connection between oesophagus and stomach.

Read the detailed description

STUDY PRODUCT Autologous BioMatrix: Obsidian (medical device class III)

STUDY POPULATION Subjects ≥ 18 years and ≤ 75 years of age scheduled for elective Ivor Lewis esophagectomy for esophageal cancer with a circular stapled intrathoracic esophagogastric anastomosis.

SAMPLE SIZE A total of 90 patients will be included in the study. ENROLEMENT PERIOD Based on an annual number of 70-80 esophagectomies in University Hospital Ghent, we predict an enrolment period of 3 years.

STUDY DURATON Considering a 3 years enrolment period and a 1 year follow up we predict a study duration of 4 years.

PRIMAIRY ANALYSIS

  • Anastomotic leak within 30 days post operatively. Anastomotic leak type I, II and III is defined according to the Esophagectomy Complications Consensus Group (ECCG).
Being tested
Obsidian
Keywords
anastomotic leakage, esophageal cancer surgery, autologous biomatrix
Medical subject headings
Anastomotic Leak

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ObsidianDevice

    To create OBSiDiAN BioMatrix, 120 ml of the the patient's blood is added to the processing unit. The Vivostat® processor unit heats, separates, centrifugates to get the plasma. Batroxobin is added. After again processing, the result is an OBSiDian syringe filled with BioMatrix Obsidian®ASG. This will be applied on the anastomosis

Study groups in NCT05713955
Study groupRoleWhat they receive
study groupExperimentalFor the study group, a unit of autologous BioMatrix OBSiDiAN will be produced. Blood sample (120ml) will be taken after randomization at the ending of the abdominal phase of the surgery. The surgeon will create an esophagogastric anastomosis, after ruling out tension or torsion. Around 1-2ml of autologous BioMatrix OBSiDiAN will be applied on the distal/or proximal resection stump before the stapled anastomose will be created. After firing the standard circular device and creation of a functional anastomosis, a further 2.5-3ml OBSiDiAN must be applied circumferentially on the outside on the anastomosis. Once application is completed, a 30 seconds waiting period is required before putting the esophagus back into the surgical field (study specific). A methylene blue leakage test or other leakage test is performed (standard of care). If there is a leak, the anastomosis will be corrected or the completed procedure has to be done again.
Receives: Device: Obsidian

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anastomotic leak

    Anastomotic leak defined according to the ECCG guidelines type I: local defect requiring no change in therapy or treated medicallly or with dietary modifications type II: localized defect requiring interventional but not surgical therapy, for example, interventional radiology drain, stent or bedside opening and packing or incision type III: localized defect requiring surgical therapy

    Measured: Absence of anastomotic leak within 30 days post operatively

Secondary outcomes (12)

  1. mortality

    in hospital mortality

    Measured: from surgery until 30 days post operative

  2. sepsis

    in hospital sepsis

    Measured: from surgery until 30 day post operative

  3. pneumonia

    in hospital pneumonia

    Measured: from surgery until 30 day post operative

  4. late anastomotic leakage

    late anastomotic leakage (ECCG type I, II and III)

    Measured: from surgery until 90 days post operative

  5. stricture

    stricture of the esophagogastric anastomosis

    Measured: from surgery until 1 year post operative

  6. inflammation WBC

    post operative inflammation (WBC)

    Measured: from date of randomisation to postoperative day 5

  7. inflammation CRP

    post operative inflammation (CRP)

    Measured: from date of randomisation to postoperative day 5

  8. ICU stay

    length of ICU stay

    Measured: from surgery until discharge or until the date of death from any cause, whichever came first, assessed up to 3 months

  9. hospital stay

    total hospital stay

    Measured: from surgery until discharge or until the date of death from any cause, whichever came first, assessed up to 3 months

  10. thoracic drainage volume

    Volume of thoracic drain

    Measured: from surgery until removal of thoracic drain within the first week postoperative

  11. thoracic drainage duration

    duration of thoracic drain

    Measured: from surgery until removal of thoracic drain within the first week postoperative

  12. intra-operative checklist

    • Hb > 8 g/dL
    • No tension on the anastomosis
    • No torsion on the anastomosis
    • Complete visibility of the anastomosis
    • Dry operation area
    • Application on the gastric stump
    • Application area of 2 cm proximal and distal of the anastomosis
    • Application completely covering the anastomosis
    • Visible white layer of fibrin sealant
    • Dry for 30 seconds

    Measured: peroperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2023
  2. Study start1 Jun 2025
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion1 Jan 2027 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05713955
Sponsor's protocol ID
BC-09974
Acronym
Obsidian ph II
Status last verified
Sep 2026
First submitted
8 Nov 2021
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Plat VD, Bootsma BT, van der Wielen N, van der Peet DL, Daams F. Autologous Activated Fibrin Sealant for the Esophageal Anastomosis: A Feasibility Study. J Surg Res. 2019 Feb;234:49-53. doi: 10.1016/j.jss.2018.08.049. Epub 2018 Sep 27.

    PubMed 30527497

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Obsidian in people with Anastomotic Leak Esophagus, run by University Hospital, Ghent at 2 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hanne Vanommeslaeghe (+3293325945, hanne.vanommeslaeghe@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anastomotic leak (time frame: Absence of anastomotic leak within 30 days post operatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05713955, which also lists 1 linked publication.

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 21 Sep 2026.

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