A New Thermo-Responsive Hyaluronic Acid Sol-Gel to Prevent Intrauterine Adhesions after Hysteroscopic Surgery: A Randomized, Non-Inferiority Trial
Open accessAbstract
PURPOSE: To investigate the efficacy and safety of a newly developed thermo-responsive sol-gel, ABT13107, for reducing the formation of intrauterine adhesions (IUAs) after hysteroscopic surgery. MATERIALS AND METHODS: In this multicenter, prospective, randomized trial (Canadian Task Force classification I), 192 women scheduled to undergo a hysteroscopic surgery at one of the eight university hospitals in South Korea were randomized into the ABT13107 group or the comparator (Hyalobarrier®) group in a 1:1 ratio. During hysteroscopic surgery, ABT13107 or Hyalobarrier® was injected to sufficiently cover the entire intrauterine cavity. RESULTS: The patients returned to their respective sites for safety assessments at postoperative weeks 1 and 4 and for efficacy assessments at postoperative week 4. The post-surgery incidence of IUAs was 23.4% in the ABT13107 group and 25.8% in the comparator group; this difference met the criteria for ABT13107 to be considered as not inferior to the comparator. No differences were found in the extent of adhesions, types of adhesions, or the cumulative American Fertility Society score between the two treatment groups. Most adverse events were mild in severity, and no serious adverse events occurred. CONCLUSION: ABT13107, a new anti-adhesive barrier containing hyaluronic acid, was not inferior to the highly viscous hyaluronic acid anti-adhesive barrier, Hyalurobarrier® in IUA formation after hysteroscopic surgery (Clinical trial registration No. NCT04007211).
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In a randomized clinical trial involving 192 women undergoing hysteroscopic surgery, ABT13107 was non-inferior to Hyalobarrier in reducing intrauterine adhesions, with no serious adverse events reported.
“In a randomized clinical trial involving 192 women undergoing hysteroscopic surgery, ABT13107 was shown to be non-inferior to Hyalobarrier in reducing intrauterine adhesions, with no serious adverse events reported.”
From Biomaterials in Postoperative Adhesion Barriers and Uterine Tissue Engineering (2025) · cites this paper as [125]
ABT13107 is a thermosensitive HA-poloxamer gel that transitions from liquid to gel at body temperature.
“A notable example is ABT13107, a thermosensitive HA–poloxamer gel that transitions from liquid to gel at body temperature.”
From Biomaterials in Postoperative Adhesion Barriers and Uterine Tissue Engineering (2025) · cites this paper as [125]
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Research works printed but not linked: 26
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Biomaterials in Postoperative Adhesion Barriers and Uterine Tissue Engineering
Fazel Anvari-Yazdi, A., Badea, I., & Chen, X. (2025) · Gels · doi:10.3390/gels11060441 · Cited by 20 · see citing works
- Authors
- Lee, D.-Y., Lee, S. R., Kim, S. K., Joo, J. K., Lee, W. S., Shin, J.-H., Cho, S., Park, J. C., & Kim, S. H.
- Affiliations
- Samsung Medical Center (KR)
- Asan Medical Center (KR)
- Pusan National University (KR)
- Medytox (KR)
- Korea University (KR)
- Yonsei University (KR)
- Keimyung University (KR)
- Corresponding author
- Park, Joon Cheol
- Kim, Sung Hoon
- ORCID
- Venue
- Yonsei Medical Journal
- Publisher
- XMLink
- Published
- 2020
- Volume
- 61
- Issue
- 10
- Pages
- 868
- ISSN
- 0513-5796 (ISSN-L)
- 1976-2437
- PMC
- PMC7515784
- OpenAlex
- W3089004718
- Cited by
- 15
- References
- 0
- Citations by year
- 2026: 2 · 2025: 2 · 2024: 2 · 2023: 3 · 2022: 2 · 2021: 3 · 2020: 1
- FWCI
- 1.37
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Yonsei Medical Journal (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- YUHSpace (Yonsei University Medical Library) (submittedVersion, cc-by-nc-nd)
- Funders
- Medytox Inc. (NCT04007211)
- Korea Health Industry Development Institute (HI17C0565)
- Topics
- Health Sciences › Medicine › Obstetrics and Gynecology › Gynecological conditions and treatments
- Health Sciences › Medicine › Surgery › Intestinal and Peritoneal Adhesions
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Reproductive Health and Contraception
- Keywords
- intrauterine adhesions, hyaluronic acid, operative hysteroscopy, postoperative adhesion prevention, non-inferiority
- MeSH terms
- Tissue Adhesions, Adult, Female, Gels, Humans, Hyaluronic Acid, Postoperative Complications, Pregnancy, Prospective Studies, Severity of Illness Index, Uterine Diseases, Hysteroscopy, Incidence, Treatment Outcome, Republic of Korea
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