Design: Ex-vivo, In-vivo, and Early Feasibility Studies.

Setting: Hospital pathology labs and operating room with subject under general anesthesia in a modified lithotomy position.

Patients or Participants: Consenting patients scheduled for hysterectomy and patients scheduled for a potentially adhesiogenic transcervical procedure: D&C for RPOC, adhesiolysis, myomectomy, polypectomy, and septoplasty.

Interventions: After designing an instillation system, a commercially available PEG-hydrogel was tested on extirpated uteri and then on seven women undergoing hysterectomy for benign indications instilling the gel transcervically prior to removal of the uterus. Uterine specimens were sectioned and inspection of the in situ formed hydrogel spacer confirmed conformance to the endometrial cavity. Then a single-arm, feasibility study involved use of the hydrogel device following transcervical procedures and postoperative a second look hysteroscopy (SLH) to evaluate the presence of de novo IUAs.

Measurements and Main Results: The hydrogel was found to cross-link within seconds and completely fill and conform to the shape of the endometrial cavity and upper cervical canal in a range of uterine cavity sizes, geometries, and pathologies, without traversing the intramural region of the fallopian tube. The hydrogel instillation procedure was well tolerated by all subjects with no adverse events. For all subjects who had a SLH there was easy unobstructed access to the uterine cavity, with none to minimal de novo IUA and visibility of all intrauterine landmarks. There were no signs of hydrogel at the time of the second look hysteroscopy.

Conclusion: Transcervical instillation of PEG-based hydrogel forms an intrauterine spacer in the presence of residual intrauterine fluids and biological materials that may be present in the uterine cavity following transcervical surgery (hysteroscopic distention fluids, blood, tissue debris). .Findings in women undergoing transcervical surgical procedures suggest that a PEG-based hydrogel spacer can be used safely.