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Inadequate insufflation during colonoscopies is common. A new rectal seal device, RECSEAL, effectively manages gas leakage, improving colonic insufflation and visualization during procedures.

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Area of Science:

  • Gastroenterology
  • Medical Device Development
  • Endoscopy

Background:

  • Inadequate insufflation during colonoscopies, caused by gas leakage, impedes luminal visualization.
  • A survey of gastroenterologists revealed a 6.6% rate of inadequate insufflation requiring intervention.

Purpose of the Study:

  • To address inadequate insufflation in colonoscopies by developing a novel rectal seal device.
  • To evaluate the efficacy of the RECSEAL device in managing insufflation leakage and improving visualization.

Main Methods:

  • Development of the RECSEAL, a silicone rectal seal device designed for safe insertion and retention in the anal canal.
  • Evaluation of RECSEAL using pressure sensors in bench, ex vivo (simulated poor anal tone), and in vivo (pig models) settings.

Main Results:

  • The RECSEAL maintained significantly higher colonic pressures (32-33 mm Hg) compared to controls (0.3-3.6 mm Hg) in both intact and injured anal sphincter models (P < .0001).
  • The device demonstrated improved lumen visualization in collapsed colons.
  • Feasibility of RECSEAL was confirmed in an in vivo pig model.

Conclusions:

  • The flexible RECSEAL effectively increases luminal pressure in the colon.
  • RECSEAL shows potential to enhance colon insufflation and visualization during colonoscopies.