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NotableRecruitment openedShow 7 more changesShow less
Primary completion moved earlier from Apr 1, 2028 to Jan 1, 2027
Study completion moved earlier from Apr 1, 2029 to Jan 1, 2027
Study sites: 1 to 2
Start date changed from estimate of Apr 1, 2025 to Jun 1, 2025
Eligibility criteria expanded, about 18 words
Secondary endpoints: details revised at 1 of 12 entries
Publications: details revised at 1 of 1 entry
NotablePhase: Not applicable to Phase 2v6Show 12 more changesShow less
Trial status: Withdrawn to Not Yet Recruiting
Primary completion date: Jul 1, 2027 to Apr 1, 2028
Start date: Jan 9, 2024 to Apr 1, 2025
Enrollment target: 0 to 90
Study sites: 0 to 1
Study completion date: Jul 1, 2028 to Apr 1, 2029
Secondary endpoints: 11 to 12
Publications: details revised at 1 of 1 entry
Study arms: 2 to 1
Eligibility criteria shortened, about 3 words
Study description expanded, about 5 words
Collaborators expanded, about 1 word
StoppedTrial status: Not Yet Recruiting to WithdrawnSponsor's reason: No enough funding and study withdrawn
Enrollment target: estimated 600 to confirmed 0
Start date changed from estimate of Dec 15, 2023 to Jan 9, 2024
v5
NotableStart date: Sep 15, 2023 to Dec 15, 2023v4
NotableStart date: Jul 1, 2023 to Sep 15, 2023v3
NotableEnrollment target: 250 to 600v2Show 6 more changesShow less
Primary completion date: Jan 1, 2027 to Jul 1, 2027
Start date: Mar 1, 2023 to Jul 1, 2023
Study completion date: Jan 1, 2027 to Jul 1, 2028
Eligibility criteria expanded, about 64 words
Secondary endpoints revised (11)
Study description shortened, about 4 words
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.