UnknownNot Applicable

Abdominal Wall Closure After Laparotomy in Oncologic Surgery

Colombia30 participantsStarted 2022-06-17

Plain-language summary

The REBUILD Study is a first-in-human evaluation of the safety and performance of REBUILD Bioabsorbable.

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patient is 18-75 years of age
✓. Patient is scheduled for oncologic, open, elective, intent-to-cure laparotomy
✓. Patient is able to provide written informed consent
✓. Patient is able and willing to comply with all study requirements

✕. Patient is scheduled for a palliative procedure
✕. Patient has had previous failed surgical repair of a ventral or incisional hernia
✕. Patient has a current infection at the intended surgical site
✕. Patient is participating in a concurrent investigational medical device study
✕. Patient is pregnant or planning on becoming pregnant during the study period
✕. Patient has a history of psychological condition, drug or alcohol misuse which may interfere with their ability to be compliant with post-operative visits.

Adverse Events

Timeframe: 12 months

Performance

Timeframe: 12 months

NCT IDNCT05041530

SponsorAbSolutions Med Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-03

Daniel Jacobs, MD