At a glance
ClinicalIndex Comparison RecordN/ACompleted· 30 enrolled
Drug / intervention
Stratafix PGA Suturedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Intrathoracic Esophagogastric Anastomosis After Robot Assisted Minimally Invasive Esophagectomy Using STRATAFIX
In Brief
An observational study evaluating Stratafix PGA Suture for Esophageal Cancer. Completed, enrolled 30 participants across 1 site.
Detailed Summary
Determine the safety and efficacy of novel suture in esophageal anastomosis. Specific Aims: 1) Determine the safety of using STRATAFIX suture in esophagogastric anastomosis by measuring anastomotic leak rate; and 2) Determine efficacy of STRATAFIX suture in esophagogastric anastomosis by measure anastomotic stricture rate.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsEsophageal Cancer
CountriesUnited States
CollaboratorsEthicon, Inc.
Timeline
N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 2015
Enrollment StartDec 2015
Primary CompletionAug 2020
TodayJul 2026
First PostedNov 20, 2015
Enrollment StartDec 1, 2015
Primary CompletionAug 25, 2020
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 10.6 years ago
Interventions
Stratafix PGA Suturedevice
Subject leak Stricture rates post procedure